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 
Otto Solutions LLC

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.

----------

Hand Sanitizer

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

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 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.

Directions

Other information

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

Kiranex 1Gal LabelDr Lucid Eucalyptus LiquidDr Lucid Rose GelDr Lucid Rose LiquidDr Lucid Eucalyptus GelDr Lucid 4% Hydrogen Peroxide 1 Gal LabelSafety First 70 Ethanol GelCompass 70% Ethanol Gel with LimoneneCompass 70% Ethanol Gel with LavenderDr Lucid 65 Ethanol 10oz LiquidDr Luid 70 IPA 10oz LabelDr Lucid 91 IPA 10oz LabelDr Lucid 70 Ethanol 10oz Gel LabelDr Lucid 70 Ethanol 10oz Liquid Label

DR LUCID 70% ETHANOL HAND SANITIZER GEL WITH ROSE 
70% ethanol hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78346-017
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78346-017-02100 mL in 1 BOTTLE; Type 0: Not a Combination Product06/14/2021
2NDC:78346-017-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product06/14/2021
3NDC:78346-017-03296 mL in 1 BOTTLE; Type 0: Not a Combination Product06/14/2021
4NDC:78346-017-046000 mL in 1 CASE; Type 0: Not a Combination Product06/14/2021
5NDC:78346-017-056033 mL in 1 CASE; Type 0: Not a Combination Product06/14/2021
6NDC:78346-017-06400 mL in 1 CASE; Type 0: Not a Combination Product06/14/2021
7NDC:78346-017-071600 mL in 1 BOTTLE; Type 0: Not a Combination Product06/14/2021
8NDC:78346-017-08600 mL in 1 CASE; Type 0: Not a Combination Product06/14/2021
9NDC:78346-017-092400 mL in 1 CASE; Type 0: Not a Combination Product06/14/2021
10NDC:78346-017-10296 mL in 1 BOTTLE; Type 0: Not a Combination Product06/14/2021
11NDC:78346-017-111000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/14/2021
12NDC:78346-017-123785 mL in 1 BOTTLE; Type 0: Not a Combination Product06/14/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/14/2021
KIRANEX 70% ETHANOL HAND SANITIZER GEL WITH EUCALYPTUS 
70% ethanol hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78346-019
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78346-019-021000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/14/2021
2NDC:78346-019-013785 mL in 1 BOTTLE; Type 0: Not a Combination Product06/14/2021
3NDC:78346-019-0315142 mL in 1 CASE; Type 0: Not a Combination Product06/14/2021
4NDC:78346-019-048000 mL in 1 CASE; Type 0: Not a Combination Product06/14/2021
5NDC:78346-019-0522712 mL in 1 CASE; Type 0: Not a Combination Product06/14/2021
6NDC:78346-019-0650 mL in 1 BOTTLE; Type 0: Not a Combination Product06/14/2021
7NDC:78346-019-07100 mL in 1 BOTTLE; Type 0: Not a Combination Product06/14/2021
8NDC:78346-019-08296 mL in 1 BOTTLE; Type 0: Not a Combination Product06/14/2021
9NDC:78346-019-0950 mL in 1 BOTTLE; Type 0: Not a Combination Product06/14/2021
10NDC:78346-019-10100 mL in 1 BOTTLE; Type 0: Not a Combination Product06/14/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/14/2021
COMPASS 70% ETHANOL HAND SANITIZER GEL WITH CITRUS 
70% ethanol hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78346-008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78346-008-013785 mL in 1 BOTTLE; Type 0: Not a Combination Product11/09/2020
2NDC:78346-008-0215142 mL in 1 CASE; Type 0: Not a Combination Product11/09/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A11/09/2020
COMPASS 70% ETHANOL HAND SANITIZER GEL WITH LAVENDER 
70% ethanol hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78346-009
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78346-009-013785 mL in 1 BOTTLE; Type 0: Not a Combination Product11/09/2020
2NDC:78346-009-0215142 mL in 1 CASE; Type 0: Not a Combination Product11/09/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A11/09/2020
DR LUCID 70% ETHANOL HAND SANITIZER GEL 
70% ethanol hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78346-006
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78346-006-05100 mL in 1 BOTTLE; Type 0: Not a Combination Product09/11/2020
2NDC:78346-006-03296 mL in 1 BOTTLE; Type 0: Not a Combination Product09/11/2020
3NDC:78346-006-013785 mL in 1 BOTTLE; Type 0: Not a Combination Product09/11/2020
4NDC:78346-006-0215142 mL in 1 CASE; Type 0: Not a Combination Product09/11/2020
5NDC:78346-006-066000 mL in 1 CASE; Type 0: Not a Combination Product09/11/2020
6NDC:78346-006-045915 mL in 1 CASE; Type 0: Not a Combination Product09/11/2020
7NDC:78346-006-085920 mL in 1 CASE; Type 0: Not a Combination Product09/11/2020
8NDC:78346-006-07296 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/11/2020
9NDC:78346-006-09600 mL in 1 CASE; Type 0: Not a Combination Product09/11/2020
10NDC:78346-006-102400 mL in 1 CASE; Type 0: Not a Combination Product09/11/2020
11NDC:78346-006-111774 mL in 1 CASE; Type 0: Not a Combination Product09/11/2020
12NDC:78346-006-127098 mL in 1 CASE; Type 0: Not a Combination Product09/11/2020
13NDC:78346-006-131774 mL in 1 CASE; Type 0: Not a Combination Product09/11/2020
14NDC:78346-006-147098 mL in 1 CASE; Type 0: Not a Combination Product09/11/2020
15NDC:78346-006-152400 mL in 1 CASE; Type 0: Not a Combination Product09/11/2020
16NDC:78346-006-1650 mL in 1 BOTTLE; Type 0: Not a Combination Product11/02/2020
17NDC:78346-006-176000 mL in 1 CASE; Type 0: Not a Combination Product11/02/2020
18NDC:78346-006-1850 mL in 1 BOTTLE; Type 0: Not a Combination Product11/02/2020
19NDC:78346-006-196000 mL in 1 CASE; Type 0: Not a Combination Product11/02/2020
20NDC:78346-006-20250000 mL in 1 DRUM; Type 0: Not a Combination Product11/17/2020
21NDC:78346-006-21208000 mL in 1 DRUM; Type 0: Not a Combination Product11/17/2020
22NDC:78346-006-221000000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product11/17/2020
23NDC:78346-006-23400 mL in 1 CASE; Type 0: Not a Combination Product11/17/2020
24NDC:78346-006-241600 mL in 1 CASE; Type 0: Not a Combination Product11/17/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/11/2020
DR LUCID 70% ETHANOL HAND SANITIZER 
70% ethanol hand sanitizer liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78346-007
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78346-007-05100 mL in 1 BOTTLE; Type 0: Not a Combination Product09/11/2020
2NDC:78346-007-03296 mL in 1 BOTTLE; Type 0: Not a Combination Product09/11/2020
3NDC:78346-007-013785 mL in 1 BOTTLE; Type 0: Not a Combination Product09/11/2020
4NDC:78346-007-0215142 mL in 1 CASE; Type 0: Not a Combination Product09/11/2020
5NDC:78346-007-066000 mL in 1 CASE; Type 0: Not a Combination Product09/11/2020
6NDC:78346-007-045920 mL in 1 CASE; Type 0: Not a Combination Product09/11/2020
7NDC:78346-007-071774 mL in 1 CASE; Type 0: Not a Combination Product09/11/2020
8NDC:78346-007-087098 mL in 1 CASE; Type 0: Not a Combination Product09/11/2020
9NDC:78346-007-09600 mL in 1 CASE; Type 0: Not a Combination Product09/11/2020
10NDC:78346-007-102400 mL in 1 CASE; Type 0: Not a Combination Product09/11/2020
11NDC:78346-007-112400 mL in 1 CASE; Type 0: Not a Combination Product09/11/2020
12NDC:78346-007-1250 mL in 1 BOTTLE; Type 0: Not a Combination Product11/02/2020
13NDC:78346-007-136000 mL in 1 CASE; Type 0: Not a Combination Product11/02/2020
14NDC:78346-007-1450 mL in 1 BOTTLE; Type 0: Not a Combination Product11/02/2020
15NDC:78346-007-156000 mL in 1 CASE; Type 0: Not a Combination Product11/02/2020
16NDC:78346-007-161500 mL in 1 CASE; Type 0: Not a Combination Product11/02/2020
17NDC:78346-007-17400 mL in 1 CASE; Type 0: Not a Combination Product11/02/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/11/2020
DR LUCID HAND SANITIZER 
65% ethanol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78346-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78346-001-34100 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
2NDC:78346-001-10296 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
3NDC:78346-001-013785 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
4NDC:78346-001-0215142 mL in 1 CASE; Type 0: Not a Combination Product03/30/2020
5NDC:78346-001-115920 mL in 1 CASE; Type 0: Not a Combination Product03/30/2020
6NDC:78346-001-356033 mL in 1 CASE; Type 0: Not a Combination Product03/30/2020
7NDC:78346-001-695920 mL in 1 CASE; Type 0: Not a Combination Product03/30/2020
8NDC:78346-001-77296 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
DR LUCID 70% IPA SANITIZER 
70% isopropanol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78346-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78346-003-01296 mL in 1 BOTTLE; Type 0: Not a Combination Product09/09/2020
2NDC:78346-003-00500 mL in 1 BOTTLE; Type 0: Not a Combination Product09/09/2020
3NDC:78346-003-105920 mL in 1 CASE; Type 0: Not a Combination Product09/09/2020
4NDC:78346-003-2412000 mL in 1 CASE; Type 0: Not a Combination Product09/09/2020
5NDC:78346-003-023785 mL in 1 BOTTLE; Type 0: Not a Combination Product09/09/2020
6NDC:78346-003-0315142 mL in 1 CASE; Type 0: Not a Combination Product09/09/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/09/2020
DR LUCID 91% IPA SANITIZER 
91% isopropanol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78346-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL91 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78346-004-00296 mL in 1 BOTTLE; Type 0: Not a Combination Product09/09/2020
2NDC:78346-004-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product09/09/2020
3NDC:78346-004-205920 mL in 1 CASE; Type 0: Not a Combination Product09/09/2020
4NDC:78346-004-1012000 mL in 1 CASE; Type 0: Not a Combination Product09/09/2020
5NDC:78346-004-023785 mL in 1 BOTTLE; Type 0: Not a Combination Product09/09/2020
6NDC:78346-004-0315142 mL in 1 CASE; Type 0: Not a Combination Product09/09/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/09/2020
SAFETY FIRST 70% ETHANOL HAND SANITIZER GEL 
70% ethanol hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78346-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78346-010-013785 mL in 1 BOTTLE; Type 0: Not a Combination Product11/09/2020
2NDC:78346-010-0215142 mL in 1 CASE; Type 0: Not a Combination Product11/09/2020
3NDC:78346-010-05208000 mL in 1 DRUM; Type 0: Not a Combination Product11/17/2020
4NDC:78346-010-06250000 mL in 1 DRUM; Type 0: Not a Combination Product11/17/2020
5NDC:78346-010-03473 mL in 1 BOTTLE; Type 0: Not a Combination Product11/09/2020
6NDC:78346-010-045678 mL in 1 CASE; Type 0: Not a Combination Product11/09/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A11/09/2020
DR LUCID 70% ETHANOL HAND SANITIZER GEL WITH EUCALYPTUS 
70% ethanol hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78346-013
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78346-013-02100 mL in 1 BOTTLE; Type 0: Not a Combination Product06/14/2021
2NDC:78346-013-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product06/14/2021
3NDC:78346-013-03296 mL in 1 CASE; Type 0: Not a Combination Product06/14/2021
4NDC:78346-013-046000 mL in 1 CASE; Type 0: Not a Combination Product06/14/2021
5NDC:78346-013-056033 mL in 1 CASE; Type 0: Not a Combination Product06/14/2021
6NDC:78346-013-062400 mL in 1 BOTTLE; Type 0: Not a Combination Product06/14/2021
7NDC:78346-013-07600 mL in 1 BOTTLE; Type 0: Not a Combination Product06/14/2021
8NDC:78346-013-08400 mL in 1 BOTTLE; Type 0: Not a Combination Product06/14/2021
9NDC:78346-013-091600 mL in 1 CASE; Type 0: Not a Combination Product06/14/2021
10NDC:78346-013-105920 mL in 1 CASE; Type 0: Not a Combination Product06/14/2021
11NDC:78346-013-111000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/14/2021
12NDC:78346-013-123785 mL in 1 BOTTLE; Type 0: Not a Combination Product06/14/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/14/2021
DR LUCID 70% ETHANOL HAND SANITIZER LIQUID WITH ROSE 
70% ethanol hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78346-018
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78346-018-02100 mL in 1 BOTTLE; Type 0: Not a Combination Product06/14/2021
2NDC:78346-018-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product06/14/2021
3NDC:78346-018-03296 mL in 1 BOTTLE; Type 0: Not a Combination Product06/14/2021
4NDC:78346-018-046000 mL in 1 CASE; Type 0: Not a Combination Product06/14/2021
5NDC:78346-018-056033 mL in 1 CASE; Type 0: Not a Combination Product06/14/2021
6NDC:78346-018-06400 mL in 1 CASE; Type 0: Not a Combination Product06/14/2021
7NDC:78346-018-071600 mL in 1 BOTTLE; Type 0: Not a Combination Product06/14/2021
8NDC:78346-018-08600 mL in 1 CASE; Type 0: Not a Combination Product06/14/2021
9NDC:78346-018-092400 mL in 1 CASE; Type 0: Not a Combination Product06/14/2021
10NDC:78346-018-101000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/14/2021
11NDC:78346-018-113785 mL in 1 BOTTLE; Type 0: Not a Combination Product06/14/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/14/2021
DR LUCID 70% ETHANOL HAND SANITIZER LIQUID WITH EUCALYPTUS 
70% ethanol hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78346-014
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78346-014-02100 mL in 1 BOTTLE; Type 0: Not a Combination Product06/14/2021
2NDC:78346-014-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product06/14/2021
3NDC:78346-014-03296 mL in 1 CASE; Type 0: Not a Combination Product06/14/2021
4NDC:78346-014-046000 mL in 1 CASE; Type 0: Not a Combination Product06/14/2021
5NDC:78346-014-056000 mL in 1 CASE; Type 0: Not a Combination Product06/14/2021
6NDC:78346-014-06400 mL in 1 BOTTLE; Type 0: Not a Combination Product06/14/2021
7NDC:78346-014-071600 mL in 1 CASE; Type 0: Not a Combination Product06/14/2021
8NDC:78346-014-08600 mL in 1 BOTTLE; Type 0: Not a Combination Product06/14/2021
9NDC:78346-014-092400 mL in 1 CASE; Type 0: Not a Combination Product06/14/2021
10NDC:78346-014-101000 mL in 1 CASE; Type 0: Not a Combination Product06/14/2021
11NDC:78346-014-113785 mL in 1 BOTTLE; Type 0: Not a Combination Product06/14/2021
12NDC:78346-014-1215140 mL in 1 CASE; Type 0: Not a Combination Product06/14/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/14/2021
Labeler - Otto Solutions LLC (117519859)
Establishment
NameAddressID/FEIBusiness Operations
Otto Solutions LLC117519859manufacture(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)

Revised: 8/2022
Document Id: e7024adf-2fbd-3e1c-e053-2a95a90af361
Set id: a6b82bf2-2362-38f2-e053-2995a90a31ed
Version: 14
Effective Time: 20220824
 
Otto Solutions LLC