HAND SANITIZER- ethyl alcohol cloth

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by All Clean Natural Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

MEDICINAL INGREDIENTS

Ethyl Alcohol, USP 80% v/v

RECOMMENDED USE

Antiseptic skin cleanser

DURATION OF USE AND RECOMMENDED DOSE:

Children 2 - 11 years Adolescents 12 - 17 years Adults 18 years and older: Supervise children when they use this product. For occasional and personal domestic use. Rub thoroughly into hands for at least 30 seconds. Allow to dry.

CAUTIONS AND WARNINGS:

Flammability warning: Keep away from open flame and sources of heat. For external use only. Keep out of reach of children. If swallowed, call a poison control centre or get medical help right away.

Contraindications:

Do not use on children/infants less than 2 years of age (unless directed by a doctor/physician/ health care practitioner/ health care provider/ health care professional.

WHEN USING

When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

STOP USE

Stop use and ask/ consult a doctor/ physician/ health care practitioner/ health care provider/ health care professional if irritation develops.

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

Children 2 - 11 years Adolescents 12 - 17 years Adults 18 years and older: Supervise children when they use this product. For occasional and personal domestic use. Rub thoroughly into hands for at least 30 seconds. Allow to dry.

Other information

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

glycerin, hydrogen peroxide, purified water

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
ethyl alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78806-500
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78806-500-40	270 in 1 CANISTER	08/14/2020
1		5 mL in 1 PACKAGE; Type 0: Not a Combination Product
2	NDC: 78806-500-50	450 in 1 CANISTER	08/14/2020
2		5 mL in 1 PACKAGE; Type 0: Not a Combination Product

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

Labeler - All Clean Natural Ltd. (203593355)