Hand Sanitizer Pure Experience

Hand Sanitizer Pure Experience Gel by

Drug Labeling and Warnings

Hand Sanitizer Pure Experience Gel 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]

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.

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Hand Sanitizer Pure Experience

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

HAND SANITIZER PURE EXPERIENCE GEL 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 70956-311
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 70956-311-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/202007/01/2022
2NDC: 70956-311-02100 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/202007/01/2022
3NDC: 70956-311-03250 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/202007/01/2022
4NDC: 70956-311-04500 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/202007/01/2022
5NDC: 70956-311-05700 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/202007/01/2022
6NDC: 70956-311-061000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/202007/01/2022
7NDC: 70956-311-071.5 mL in 1 BAG; Type 0: Not a Combination Product06/01/202007/01/2022
8NDC: 70956-311-083780 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/202007/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/01/202007/01/2022
Labeler - Absara Cosmetics S.A.P.I DE C.V. (816161236)
Establishment
NameAddressID/FEIBusiness Operations
Absara Cosmetics S.A.P.I DE C.V.816161236manufacture(70956-311)

Revised: 9/2022
Document Id: 6c79f61d-2e4a-48ac-a892-173039ecbbaf
Set id: adcb7995-69a7-4060-83fe-32d6ff631f6d
Version: 2
Effective Time: 20220914