HAND SANITIZER- alcohol cloth

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by CARE + 1 LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Ethyl Alcohol 75% 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

WHEN USING

When using this product

Avoid contact with eyes. In case of contact with eyes, rinse eyes thoroughly with water.

STOP USE

Stop use and ask a doctor if irritation or rash appears and lasts

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

• Open lid, pull back reseable label, remove a wipe for use.
• Reseal back after use to avoid evaporation of alcohol

Other information

• Store between 15-30C (59-86F)
• Dispose of wipes in the proper container
• Do not flush down the toilet

Inactive ingredients

water (aqua), glycerin, Aloe arbadensis leaf extract (Alove Vera), Tocopheryl acetate (Vitamin E)

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:

Alcohol (75%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
Glycerol (1.45% v/v).
Hydrogen peroxide (0.125% v/v).
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.

PRINCIPAL DISPLAY PANEL

NDC: 80072-002-10

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80072-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)	0.0005 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	0.003 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	0.246 mL  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.0005 mL  in 100 mL

Product Characteristics
Color		Score
Shape	RECTANGLE (CLOTH)	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80072-002-10	10 mL in 1 BAG; Type 0: Not a Combination Product	11/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	11/30/2020

Labeler - CARE + 1 LLC (044686753)