OTC Medication Information: Liquid Hand Sanitizer

LIQUID HAND SANITIZER- alcohol solution
Absara Cosmetics S.A.P.I DE C.V.

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.

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.

Children under 6yrs old to use under adult supervision.

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

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

LIQUID HAND SANITIZER alcohol solution

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

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (ALCOHOL) ALCOHOL 80 L in 100 L

Inactive Ingredients Ingredient Name Strength GLYCERIN WATER DMDM HYDANTOIN ALOE VERA LEAF

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:70956-500-01 3.78 L in 1 BOTTLE None

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	Operations
Absara Cosmetics S.A.P.I DE C.V.		816161236	manufacture (70956-500)

Revised: 05/2020 Absara Cosmetics S.A.P.I DE C.V.