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

image description
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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.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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