LIQUID HAND SANITIZER- alcohol solution

Liquid Hand Sanitizer by

Drug Labeling and Warnings

Liquid Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Absara Cosmetics S.A.P.I DE C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antimicrobial

Purpose

Antiseptic, Hand Sanitizer

Use

Hand sanitizer to help reduce bacteria on the skin.

Warnings

Flammable. Keep away from fire or flame. For external use only.

WHEN USING

Children under 6yrs old to use under adult supervision.

STOP USE

In case of irritation, discontinue use and consult your doctor.

KEEP OUT OF REACH OF CHILDREN

Do not ingest, if swallowed seek medical help. Avoid contact with eyes. Keep out of reach of children.

Directions

Apply the Gel on the hands and rub gently for 20 seconds until the product evaporates.

Other information

Store below 106 F (41 C).  May discolor certain fabrics or surfaces.

Inactive ingredients

demineralized water, glycerin, dmdm hydantoin, aloe barbadensis extract, iodopropynyl butylcarbamate, butylene glycol.

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

LIQUID HAND SANITIZER 
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70956-500
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
DMDM HYDANTOIN (UNII: BYR0546TOW)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70956-500-01	3.78 L in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/01/2020

Labeler - Absara Cosmetics S.A.P.I DE C.V. (816161236)

Establishment
Name	Address	ID/FEI	Business Operations
Absara Cosmetics S.A.P.I DE C.V.		816161236	manufacture(70956-500)