DailyMed - DR LUCID 70% ETHANOL HAND SANITIZER GEL WITH ROSE- 70% ethanol hand sanitizer gel KIRANEX 70% ETHANOL HAND SANITIZER GEL WITH EUCALYPTUS- 70% ethanol hand sanitizer gel COMPASS 70% ETHANOL HAND SANITIZER GEL WITH CITRUS- 70% ethanol hand sanitizer gel COMPASS 70% ETHANOL HAND SANITIZER GEL WITH LAVENDER- 70% ethanol hand sanitizer gel DR LUCID 70% ETHANOL HAND SANITIZER GEL- 70% ethanol hand sanitizer gel DR LUCID 70% ETHANOL HAND SANITIZER- 70% ethanol hand sanitizer liquid DR LUCID HAND SANITIZER- 65% ethanol gel DR LUCID 70% IPA SANITIZER- 70% isopropanol liquid DR LUCID 91% IPA SANITIZER- 91% isopropanol liquid SAFETY FIRST 70% ETHANOL HAND SANITIZER GEL- 70% ethanol hand sanitizer gel DR LUCID 70% ETHANOL HAND SANITIZER GEL WITH EUCALYPTUS- 70% ethanol hand sanitizer gel DR LUCID 70% ETHANOL HAND SANITIZER LIQUID WITH ROSE- 70% ethanol hand sanitizer gel DR LUCID 70% ETHANOL HAND SANITIZER LIQUID WITH EUCALYPTUS- 70% ethanol hand sanitizer gel

Contains inactivated NDC Code(s)
NDC Code(s): 78346-001-01, 78346-001-02, 78346-001-10, 78346-001-11, view more
78346-001-34, 78346-001-35, 78346-001-69, 78346-001-77, 78346-003-00, 78346-003-01, 78346-003-02, 78346-003-03, 78346-003-10, 78346-003-24, 78346-004-00, 78346-004-01, 78346-004-02, 78346-004-03, 78346-004-10, 78346-004-20, 78346-006-01, 78346-006-02, 78346-006-03, 78346-006-04, 78346-006-05, 78346-006-06, 78346-006-07, 78346-006-08, 78346-006-09, 78346-006-10, 78346-006-11, 78346-006-12, 78346-006-13, 78346-006-14, 78346-006-15, 78346-006-16, 78346-006-17, 78346-006-18, 78346-006-19, 78346-006-20, 78346-006-21, 78346-006-22, 78346-006-23, 78346-006-24, 78346-007-01, 78346-007-02, 78346-007-03, 78346-007-04, 78346-007-05, 78346-007-06, 78346-007-07, 78346-007-08, 78346-007-09, 78346-007-10, 78346-007-11, 78346-007-12, 78346-007-13, 78346-007-14, 78346-007-15, 78346-007-16, 78346-007-17, 78346-008-01, 78346-008-02, 78346-009-01, 78346-009-02, 78346-010-01, 78346-010-02, 78346-010-03, 78346-010-04, 78346-010-05, 78346-010-06, 78346-013-01, 78346-013-02, 78346-013-03, 78346-013-04, 78346-013-05, 78346-013-06, 78346-013-07, 78346-013-08, 78346-013-09, 78346-013-10, 78346-013-11, 78346-013-12, 78346-014-01, 78346-014-02, 78346-014-03, 78346-014-04, 78346-014-05, 78346-014-06, 78346-014-07, 78346-014-08, 78346-014-09, 78346-014-10, 78346-014-11, 78346-014-12, 78346-017-01, 78346-017-02, 78346-017-03, 78346-017-04, 78346-017-05, 78346-017-06, 78346-017-07, 78346-017-08, 78346-017-09, 78346-017-10, 78346-017-11, 78346-017-12, 78346-018-01, 78346-018-02, 78346-018-03, 78346-018-04, 78346-018-05, 78346-018-06, 78346-018-07, 78346-018-08, 78346-018-09, 78346-018-10, 78346-018-11, 78346-019-01, 78346-019-02, 78346-019-03, 78346-019-04, 78346-019-05, 78346-019-06, 78346-019-07, 78346-019-08, 78346-019-09, 78346-019-10
Packager: Otto Solutions LLC

Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated August 24, 2022

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

Download DRUG LABEL INFO: PDF XML
Official Label (Printer Friendly)

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SPL UNCLASSIFIED SECTION
This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:
1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
2. Glycerol (1.45% v/v).
3. Hydrogen peroxide (0.125% v/v).
4. Sterile distilled water or boiled cold water.
The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.
Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic
Purpose

Antiseptic, Hand Sanitizer
Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
Warnings

For external use only. Flammable. Keep away from heat or flame
Do not use
- in children less than 2 months of age
- on open skin wounds
WHEN USING

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
STOP USE

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Place enough product on hands to cover all surfaces. Rub hands together until dry.
- Supervise children under 6 years of age when using this product to avoid swallowing.
Other information
- Store between 15-30C (59-86F)
- Avoid freezing and excessive heat above 40C (104F)
Inactive ingredients

glycerin, hydrogen peroxide, purified water USP
Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

DR LUCID 70% ETHANOL HAND SANITIZER GEL WITH ROSE
70% ethanol hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:78346-017
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
FRAGRANCE FLORAL ORC0902236 (UNII: R66Z4YW3X0)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 mL in 100 mL
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)
ROSE OIL (UNII: WUB68Y35M7)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:78346-017-02	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/14/2021
2	NDC:78346-017-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/14/2021
3	NDC:78346-017-03	296 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/14/2021
4	NDC:78346-017-04	6000 mL in 1 CASE; Type 0: Not a Combination Product	06/14/2021
5	NDC:78346-017-05	6033 mL in 1 CASE; Type 0: Not a Combination Product	06/14/2021
6	NDC:78346-017-06	400 mL in 1 CASE; Type 0: Not a Combination Product	06/14/2021
7	NDC:78346-017-07	1600 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/14/2021
8	NDC:78346-017-08	600 mL in 1 CASE; Type 0: Not a Combination Product	06/14/2021
9	NDC:78346-017-09	2400 mL in 1 CASE; Type 0: Not a Combination Product	06/14/2021
10	NDC:78346-017-10	296 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/14/2021
11	NDC:78346-017-11	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/14/2021
12	NDC:78346-017-12	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/14/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	06/14/2021

KIRANEX 70% ETHANOL HAND SANITIZER GEL WITH EUCALYPTUS
70% ethanol hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:78346-019
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 mL in 100 mL
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)
EUCALYPTUS OIL (UNII: 2R04ONI662)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:78346-019-02	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/14/2021
2	NDC:78346-019-01	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/14/2021
3	NDC:78346-019-03	15142 mL in 1 CASE; Type 0: Not a Combination Product	06/14/2021
4	NDC:78346-019-04	8000 mL in 1 CASE; Type 0: Not a Combination Product	06/14/2021
5	NDC:78346-019-05	22712 mL in 1 CASE; Type 0: Not a Combination Product	06/14/2021
6	NDC:78346-019-06	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/14/2021
7	NDC:78346-019-07	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/14/2021
8	NDC:78346-019-08	296 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/14/2021
9	NDC:78346-019-09	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/14/2021
10	NDC:78346-019-10	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/14/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	06/14/2021

COMPASS 70% ETHANOL HAND SANITIZER GEL WITH CITRUS
70% ethanol hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:78346-008
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
LIMONENE, (+)- (UNII: GFD7C86Q1W)
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 mL in 100 mL
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:78346-008-01	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/09/2020
2	NDC:78346-008-02	15142 mL in 1 CASE; Type 0: Not a Combination Product	11/09/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	11/09/2020

COMPASS 70% ETHANOL HAND SANITIZER GEL WITH LAVENDER
70% ethanol hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:78346-009
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
LAVENDER OIL (UNII: ZBP1YXW0H8)
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 mL in 100 mL
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:78346-009-01	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/09/2020
2	NDC:78346-009-02	15142 mL in 1 CASE; Type 0: Not a Combination Product	11/09/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	11/09/2020

DR LUCID 70% ETHANOL HAND SANITIZER GEL
70% ethanol hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:78346-006
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 mL in 100 mL
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:78346-006-05	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/11/2020
2	NDC:78346-006-03	296 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/11/2020
3	NDC:78346-006-01	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/11/2020
4	NDC:78346-006-02	15142 mL in 1 CASE; Type 0: Not a Combination Product	09/11/2020
5	NDC:78346-006-06	6000 mL in 1 CASE; Type 0: Not a Combination Product	09/11/2020
6	NDC:78346-006-04	5915 mL in 1 CASE; Type 0: Not a Combination Product	09/11/2020
7	NDC:78346-006-08	5920 mL in 1 CASE; Type 0: Not a Combination Product	09/11/2020
8	NDC:78346-006-07	296 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	09/11/2020
9	NDC:78346-006-09	600 mL in 1 CASE; Type 0: Not a Combination Product	09/11/2020
10	NDC:78346-006-10	2400 mL in 1 CASE; Type 0: Not a Combination Product	09/11/2020
11	NDC:78346-006-11	1774 mL in 1 CASE; Type 0: Not a Combination Product	09/11/2020
12	NDC:78346-006-12	7098 mL in 1 CASE; Type 0: Not a Combination Product	09/11/2020
13	NDC:78346-006-13	1774 mL in 1 CASE; Type 0: Not a Combination Product	09/11/2020
14	NDC:78346-006-14	7098 mL in 1 CASE; Type 0: Not a Combination Product	09/11/2020
15	NDC:78346-006-15	2400 mL in 1 CASE; Type 0: Not a Combination Product	09/11/2020
16	NDC:78346-006-16	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/02/2020
17	NDC:78346-006-17	6000 mL in 1 CASE; Type 0: Not a Combination Product	11/02/2020
18	NDC:78346-006-18	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/02/2020
19	NDC:78346-006-19	6000 mL in 1 CASE; Type 0: Not a Combination Product	11/02/2020
20	NDC:78346-006-20	250000 mL in 1 DRUM; Type 0: Not a Combination Product	11/17/2020
21	NDC:78346-006-21	208000 mL in 1 DRUM; Type 0: Not a Combination Product	11/17/2020
22	NDC:78346-006-22	1000000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product	11/17/2020
23	NDC:78346-006-23	400 mL in 1 CASE; Type 0: Not a Combination Product	11/17/2020
24	NDC:78346-006-24	1600 mL in 1 CASE; Type 0: Not a Combination Product	11/17/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	09/11/2020

DR LUCID 70% ETHANOL HAND SANITIZER
70% ethanol hand sanitizer liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:78346-007
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 mL in 100 mL
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:78346-007-05	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/11/2020
2	NDC:78346-007-03	296 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/11/2020
3	NDC:78346-007-01	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/11/2020
4	NDC:78346-007-02	15142 mL in 1 CASE; Type 0: Not a Combination Product	09/11/2020
5	NDC:78346-007-06	6000 mL in 1 CASE; Type 0: Not a Combination Product	09/11/2020
6	NDC:78346-007-04	5920 mL in 1 CASE; Type 0: Not a Combination Product	09/11/2020
7	NDC:78346-007-07	1774 mL in 1 CASE; Type 0: Not a Combination Product	09/11/2020
8	NDC:78346-007-08	7098 mL in 1 CASE; Type 0: Not a Combination Product	09/11/2020
9	NDC:78346-007-09	600 mL in 1 CASE; Type 0: Not a Combination Product	09/11/2020
10	NDC:78346-007-10	2400 mL in 1 CASE; Type 0: Not a Combination Product	09/11/2020
11	NDC:78346-007-11	2400 mL in 1 CASE; Type 0: Not a Combination Product	09/11/2020
12	NDC:78346-007-12	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/02/2020
13	NDC:78346-007-13	6000 mL in 1 CASE; Type 0: Not a Combination Product	11/02/2020
14	NDC:78346-007-14	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/02/2020
15	NDC:78346-007-15	6000 mL in 1 CASE; Type 0: Not a Combination Product	11/02/2020
16	NDC:78346-007-16	1500 mL in 1 CASE; Type 0: Not a Combination Product	11/02/2020
17	NDC:78346-007-17	400 mL in 1 CASE; Type 0: Not a Combination Product	11/02/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	09/11/2020

DR LUCID HAND SANITIZER
65% ethanol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:78346-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	65 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 mL in 100 mL
WATER (UNII: 059QF0KO0R)
METHYLCELLULOSE, UNSPECIFIED (UNII: Z944H5SN0H)	1.3 g in 100 mL

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:78346-001-34	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
2	NDC:78346-001-10	296 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
3	NDC:78346-001-01	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
4	NDC:78346-001-02	15142 mL in 1 CASE; Type 0: Not a Combination Product	03/30/2020
5	NDC:78346-001-11	5920 mL in 1 CASE; Type 0: Not a Combination Product	03/30/2020
6	NDC:78346-001-35	6033 mL in 1 CASE; Type 0: Not a Combination Product	03/30/2020
7	NDC:78346-001-69	5920 mL in 1 CASE; Type 0: Not a Combination Product	03/30/2020
8	NDC:78346-001-77	296 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/30/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	03/30/2020

DR LUCID 70% IPA SANITIZER
70% isopropanol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:78346-003
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	70 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:78346-003-01	296 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/09/2020
2	NDC:78346-003-00	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/09/2020
3	NDC:78346-003-10	5920 mL in 1 CASE; Type 0: Not a Combination Product	09/09/2020
4	NDC:78346-003-24	12000 mL in 1 CASE; Type 0: Not a Combination Product	09/09/2020
5	NDC:78346-003-02	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/09/2020
6	NDC:78346-003-03	15142 mL in 1 CASE; Type 0: Not a Combination Product	09/09/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	09/09/2020

DR LUCID 91% IPA SANITIZER
91% isopropanol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:78346-004
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	91 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:78346-004-00	296 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/09/2020
2	NDC:78346-004-01	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/09/2020
3	NDC:78346-004-20	5920 mL in 1 CASE; Type 0: Not a Combination Product	09/09/2020
4	NDC:78346-004-10	12000 mL in 1 CASE; Type 0: Not a Combination Product	09/09/2020
5	NDC:78346-004-02	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/09/2020
6	NDC:78346-004-03	15142 mL in 1 CASE; Type 0: Not a Combination Product	09/09/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	09/09/2020

SAFETY FIRST 70% ETHANOL HAND SANITIZER GEL
70% ethanol hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:78346-010
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)
EUCALYPTUS OIL (UNII: 2R04ONI662)
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 mL in 100 mL
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:78346-010-01	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/09/2020
2	NDC:78346-010-02	15142 mL in 1 CASE; Type 0: Not a Combination Product	11/09/2020
3	NDC:78346-010-05	208000 mL in 1 DRUM; Type 0: Not a Combination Product	11/17/2020
4	NDC:78346-010-06	250000 mL in 1 DRUM; Type 0: Not a Combination Product	11/17/2020
5	NDC:78346-010-03	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/09/2020
6	NDC:78346-010-04	5678 mL in 1 CASE; Type 0: Not a Combination Product	11/09/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	11/09/2020

DR LUCID 70% ETHANOL HAND SANITIZER GEL WITH EUCALYPTUS
70% ethanol hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:78346-013
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 mL in 100 mL
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)
EUCALYPTUS OIL (UNII: 2R04ONI662)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:78346-013-02	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/14/2021
2	NDC:78346-013-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/14/2021
3	NDC:78346-013-03	296 mL in 1 CASE; Type 0: Not a Combination Product	06/14/2021
4	NDC:78346-013-04	6000 mL in 1 CASE; Type 0: Not a Combination Product	06/14/2021
5	NDC:78346-013-05	6033 mL in 1 CASE; Type 0: Not a Combination Product	06/14/2021
6	NDC:78346-013-06	2400 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/14/2021
7	NDC:78346-013-07	600 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/14/2021
8	NDC:78346-013-08	400 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/14/2021
9	NDC:78346-013-09	1600 mL in 1 CASE; Type 0: Not a Combination Product	06/14/2021
10	NDC:78346-013-10	5920 mL in 1 CASE; Type 0: Not a Combination Product	06/14/2021
11	NDC:78346-013-11	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/14/2021
12	NDC:78346-013-12	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/14/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	06/14/2021

DR LUCID 70% ETHANOL HAND SANITIZER LIQUID WITH ROSE
70% ethanol hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:78346-018
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
ROSE OIL (UNII: WUB68Y35M7)
FRAGRANCE FLORAL ORC0902236 (UNII: R66Z4YW3X0)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 mL in 100 mL
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:78346-018-02	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/14/2021
2	NDC:78346-018-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/14/2021
3	NDC:78346-018-03	296 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/14/2021
4	NDC:78346-018-04	6000 mL in 1 CASE; Type 0: Not a Combination Product	06/14/2021
5	NDC:78346-018-05	6033 mL in 1 CASE; Type 0: Not a Combination Product	06/14/2021
6	NDC:78346-018-06	400 mL in 1 CASE; Type 0: Not a Combination Product	06/14/2021
7	NDC:78346-018-07	1600 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/14/2021
8	NDC:78346-018-08	600 mL in 1 CASE; Type 0: Not a Combination Product	06/14/2021
9	NDC:78346-018-09	2400 mL in 1 CASE; Type 0: Not a Combination Product	06/14/2021
10	NDC:78346-018-10	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/14/2021
11	NDC:78346-018-11	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/14/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	06/14/2021

DR LUCID 70% ETHANOL HAND SANITIZER LIQUID WITH EUCALYPTUS
70% ethanol hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:78346-014
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 mL in 100 mL
WATER (UNII: 059QF0KO0R)
EUCALYPTUS OIL (UNII: 2R04ONI662)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:78346-014-02	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/14/2021
2	NDC:78346-014-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/14/2021
3	NDC:78346-014-03	296 mL in 1 CASE; Type 0: Not a Combination Product	06/14/2021
4	NDC:78346-014-04	6000 mL in 1 CASE; Type 0: Not a Combination Product	06/14/2021
5	NDC:78346-014-05	6000 mL in 1 CASE; Type 0: Not a Combination Product	06/14/2021
6	NDC:78346-014-06	400 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/14/2021
7	NDC:78346-014-07	1600 mL in 1 CASE; Type 0: Not a Combination Product	06/14/2021
8	NDC:78346-014-08	600 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/14/2021
9	NDC:78346-014-09	2400 mL in 1 CASE; Type 0: Not a Combination Product	06/14/2021
10	NDC:78346-014-10	1000 mL in 1 CASE; Type 0: Not a Combination Product	06/14/2021
11	NDC:78346-014-11	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/14/2021
12	NDC:78346-014-12	15140 mL in 1 CASE; Type 0: Not a Combination Product	06/14/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	06/14/2021

Labeler - Otto Solutions LLC (117519859)

Name	Address	ID/FEI	Business Operations
Establishment
Otto Solutions LLC		117519859	manufacture(78346-001, 78346-003, 78346-004, 78346-006, 78346-007, 78346-008, 78346-009, 78346-010, 78346-019, 78346-013, 78346-014, 78346-018, 78346-017)

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Published Date (What is this?)	Version	Files
Aug 26, 2022	14 (current)	download
Aug 4, 2022	13	download
Jun 9, 2022	12	download
Feb 24, 2022	11	download
Dec 2, 2021	10	download
Jun 15, 2021	9	download
Feb 4, 2021	8	download
Jan 5, 2021	7	download
Nov 19, 2020	6	download
Nov 5, 2020	5	download
Sep 17, 2020	4	download
Sep 16, 2020	3	download
Aug 27, 2020	2	download
Jun 1, 2020	1	download

	RxCUI	RxNorm NAME	RxTTY
1	581662	ethanol 70 % Topical Gel	PSN
2	581662	ethanol 0.7 ML/ML Topical Gel	SCD
3	581662	ethanol 70 % Topical Gel	SY
4	581662	ethyl alcohol 70 % Topical Gel	SY

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	NDC
1	78346-001-01 (inactivated)
2	78346-001-02 (inactivated)
3	78346-001-10 (inactivated)
4	78346-001-11 (inactivated)
5	78346-001-34 (inactivated)
6	78346-001-35 (inactivated)
7	78346-001-69 (inactivated)
8	78346-001-77 (inactivated)
9	78346-003-00
10	78346-003-01
11	78346-003-02
12	78346-003-03
13	78346-003-10
14	78346-003-24
15	78346-004-00 (inactivated)
16	78346-004-01 (inactivated)
17	78346-004-02 (inactivated)
18	78346-004-03 (inactivated)
19	78346-004-10 (inactivated)
20	78346-004-20 (inactivated)
21	78346-006-01 (inactivated)
22	78346-006-02 (inactivated)
23	78346-006-03 (inactivated)
24	78346-006-04 (inactivated)
25	78346-006-05 (inactivated)
26	78346-006-06 (inactivated)
27	78346-006-07 (inactivated)
28	78346-006-08 (inactivated)
29	78346-006-09 (inactivated)
30	78346-006-10 (inactivated)
31	78346-006-11 (inactivated)
32	78346-006-12 (inactivated)
33	78346-006-13 (inactivated)
34	78346-006-14 (inactivated)
35	78346-006-15 (inactivated)
36	78346-006-16 (inactivated)
37	78346-006-17 (inactivated)
38	78346-006-18 (inactivated)
39	78346-006-19 (inactivated)
40	78346-006-20 (inactivated)
41	78346-006-21 (inactivated)
42	78346-006-22 (inactivated)
43	78346-006-23 (inactivated)
44	78346-006-24 (inactivated)
45	78346-007-01
46	78346-007-02
47	78346-007-03
48	78346-007-04
49	78346-007-05
50	78346-007-06
51	78346-007-07
52	78346-007-08
53	78346-007-09
54	78346-007-10
55	78346-007-11
56	78346-007-12
57	78346-007-13
58	78346-007-14
59	78346-007-15
60	78346-007-16
61	78346-007-17
62	78346-008-01 (inactivated)
63	78346-008-02 (inactivated)
64	78346-009-01
65	78346-009-02
66	78346-010-01
67	78346-010-02
68	78346-010-03
69	78346-010-04
70	78346-010-05
71	78346-010-06
72	78346-013-01
73	78346-013-02
74	78346-013-03
75	78346-013-04
76	78346-013-05
77	78346-013-06
78	78346-013-07
79	78346-013-08
80	78346-013-09
81	78346-013-10
82	78346-013-11
83	78346-013-12
84	78346-014-01
85	78346-014-02
86	78346-014-03
87	78346-014-04
88	78346-014-05
89	78346-014-06
90	78346-014-07
91	78346-014-08
92	78346-014-09
93	78346-014-10
94	78346-014-11
95	78346-014-12
96	78346-017-01
97	78346-017-02
98	78346-017-03
99	78346-017-04
100	78346-017-05
101	78346-017-06
102	78346-017-07
103	78346-017-08
104	78346-017-09
105	78346-017-10
106	78346-017-11
107	78346-017-12
108	78346-018-01 (inactivated)
109	78346-018-02 (inactivated)
110	78346-018-03 (inactivated)
111	78346-018-04 (inactivated)
112	78346-018-05 (inactivated)
113	78346-018-06 (inactivated)
114	78346-018-07 (inactivated)
115	78346-018-08 (inactivated)
116	78346-018-09
117	78346-018-10 (inactivated)
118	78346-018-11 (inactivated)
119	78346-019-01
120	78346-019-02
121	78346-019-03
122	78346-019-04
123	78346-019-05
124	78346-019-06
125	78346-019-07
126	78346-019-08
127	78346-019-09
128	78346-019-10

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If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.