HAND SANITIZER- ethyl alcohol aerosol, spray
HAND SANITIZER- ethyl alcohol aerosol, spray
Singtech Inc.

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.

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100%Klean Hand Sanitizers Scented

Active Ingredient(s)

Isopropyl Alcohol 70% v/v. Purpose: Antiseptic

Hydrogen Peroxide 4% Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease.

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 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

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

water, glycerin, natural and artificial fragrances.

Package Label - Principal Display Panel

75334-034-03
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

75334-031-03
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

75334-032-03
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

75334-033-03
Principal Display Panel

75334-025-03
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HAND SANITIZER
ethyl alcohol aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:75334-031
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	4 mL in 100 mL
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
PEPPERMINT (UNII: V95R5KMY2B)
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL in 100 mL
WATER (UNII: 059QF0KO0R)
VACCINIUM MYRTILLUS ANTHOCYANOSIDES (UNII: R911H793SU)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:75334-031-03	119 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

HAND SANITIZER
ethyl alcohol aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:75334-032
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	4 mL in 100 mL
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
VANILLA (UNII: Q74T35078H)
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL in 100 mL
WATER (UNII: 059QF0KO0R)
LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:75334-032-03	119 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

HAND SANITIZER
ethyl alcohol aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:75334-033
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	4 mL in 100 mL
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
VANILLIN (UNII: CHI530446X)
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL in 100 mL
WATER (UNII: 059QF0KO0R)
PEPPERMINT (UNII: V95R5KMY2B)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:75334-033-03	119 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

HAND SANITIZER
ethyl alcohol aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:75334-034
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	4 mL in 100 mL
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
WATER (UNII: 059QF0KO0R)
COCONUT OIL (UNII: Q9L0O73W7L)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:75334-034-03	119 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

HAND SANITIZER
ethyl alcohol aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:75334-035
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)	4 mL in 100 mL
WATER (UNII: 059QF0KO0R)
ORANGE OIL TERPENELESS (UNII: L8B7EWV9I7)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:75334-035-03	119 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

Labeler - Singtech Inc. (050391348)

Name	Address	ID/FEI	Business Operations
Establishment
Singtech Inc.		050391348	relabel(75334-031)

Revised: 1/2021

Document Id: b95bb524-6eca-25b1-e053-2995a90a3309

Set id: a9f537cc-a82b-7aa0-e053-2a95a90a0974

Version: 5

Effective Time: 20210120

Singtech Inc.