OTC Medication Information: Hand Sanitizer Pure Experience Gel

HAND SANITIZER PURE EXPERIENCE GEL- alcohol gel
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.

DRUG FACTS

Active Ingredient

Ethyl Alcohol 70% v/v

Purpose

Antimicrobial

Use:

Hand sanitizer to help reduce bacteria on the skin.

Warnings

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

Do not ingest, if swallowed seek medical help. Avoid contact with eyes.

Keep out of reach of children. Children under 6yrs old to use under adult supervision.

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

Directions:

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

Other Information:

Store below 106ºF (41 ºC). May discolor certain fabrics or surfaces.

Inactive ingredients

Demineralized water, glycerin, carbomero, *fragrance, trietanolamina, dmdm hydantoin, aloe barbadensis extract, iodopropynyl butylcarbamate.

*May contain this ingredient.

Package Labeling

Product Label
(click image for full-size original)

HAND SANITIZER PURE EXPERIENCE GEL
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70956-311
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 0.7 mL in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
GLYCERIN
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
DMDM HYDANTOIN
ALOE VERA LEAF
IODOPROPYNYL BUTYLCARBAMATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70956-311-01 60 mL in 1 BOTTLE None
2 NDC:70956-311-02 100 mL in 1 BOTTLE None
3 NDC:70956-311-03 250 mL in 1 BOTTLE None
4 NDC:70956-311-04 500 mL in 1 BOTTLE None
5 NDC:70956-311-05 700 mL in 1 BOTTLE None
6 NDC:70956-311-06 1000 mL in 1 BOTTLE None
7 NDC:70956-311-07 1.5 mL in 1 BAG None
8 NDC:70956-311-08 3780 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 06/01/2020
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 (70956-311)

Revised: 06/2020 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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