Hand Sanitizer by COSMETIC LAB INC

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by COSMETIC LAB INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER- alcohol gel 
COSMETIC LAB 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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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 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

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

236 mL NDC: 00000-000-00

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76569-113
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	66 kg  in 100 kg

Inactive Ingredients
Ingredient Name	Strength
HAMAMELIS VIRGINIANA LEAF WATER (UNII: 8FP93ED6H2)	0.01 kg  in 100 kg
CITRUS BERGAMIA WHOLE (UNII: 14YV5375VD)	0.05 kg  in 100 kg
CITRUS LIMON FRUIT OIL (UNII: 0HNC1J1YED)	0.05 kg  in 100 kg
LAVANDULA ANGUSTIFOLIA WHOLE (UNII: 51217XIL5L)	0.05 kg  in 100 kg
GLYCERIN (UNII: PDC6A3C0OX)	3 kg  in 100 kg
WATER (UNII: 059QF0KO0R)	30.558 kg  in 100 kg
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.001 kg  in 100 kg
CAPRYLIC/CAPRIC MONO/DI-GLYCERIDES (UNII: U72Q2I8C85)	0.05 kg  in 100 kg
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)	0.03 kg  in 100 kg
MENTHA PIPERITA (UNII: 79M2M2UDA9)	0.001 kg  in 100 kg

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76569-113-09	0.236 kg in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/03/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/03/2020	05/25/2023

Labeler - COSMETIC LAB INC (196409143)

Registrant - COSMETIC LAB INC (196409143)

Establishment
Name	Address	ID/FEI	Business Operations
COSMETIC LAB INC		196409143	manufacture(76569-113)

Revised: 6/2023

Document Id: ff4b0528-39a2-80d5-e053-6394a90a8a83

34390-5

Set id: ad53b181-90e2-0ab6-e053-2a95a90a4c8e

Version: 4

Effective Time: 20230629