HAND SANITIZER RINSE FREE- alcohol gel

Hand Sanitizer Rinse Free by

Drug Labeling and Warnings

Hand Sanitizer Rinse Free 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]

DRUG FACTS

Active Ingredient

Ethyl Alcohol 80% v/v

Purpose

Antimicrobial

Uses

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, carbomer, triethanolamine, dmdm hydantoin, aloe barbadensis extract, iodopropynyl butylcarbamate, butylene glycol.

Package Labeling: 70956-520-01, 02 and 03

INGREDIENTS AND APPEARANCE

HAND SANITIZER RINSE FREE 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70956-520
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.8 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)
DMDM HYDANTOIN (UNII: BYR0546TOW)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70956-520-01	330 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2020
2	NDC: 70956-520-02	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2020
3	NDC: 70956-520-03	700 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2020
4	NDC: 70956-520-04	1.5 mL in 1 BAG; Type 0: Not a Combination Product	04/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	04/01/2020

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(70956-520)