HAND SANITIZER GEL 70% ALCOHOL

HAND SANITIZER 70 ALCOHOL by

Drug Labeling and Warnings

HAND SANITIZER 70 ALCOHOL 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 70 ALCOHOL- 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 GEL 70% ALCOHOL

Drug Facts

Active Ingredients

Ethyl Alcohol 70% v/v

Purpose

Antiseptic

Uses

To decrease bacteria on the skin when water and soap are not available.

Warnings

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

When using this product:

Keep out of eyes. In case of contact with eyes, rinse thoroughly with water.

Do not use on broken or irritated skin.

Stop use and ask a doctor if

irritation or redness develop and last more than 3 days.

Keep out of the reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply enough product to wet hands. Rub hands together until dry. Supervise children in use of this product.

Other Information

• Do not store above 105 F° (40°C)
• May discolor some fabrics and wood surfaces.

Inactive Ingredients

Demineralized water, glycerin, carbomer, 1fragrance, triethanolamine, dmdm hydantoin, aloe barbadensis extract, iodopropynyl butylcarbamate, butylene glycol.

1 May contain this ingredient

Questions or comments?

(281) 882-8850

Distributed by Interbrands Group, LLC
331 Corporate Woods Dr, Suite A4,
Magnolia, TX 77354

PRINCIPAL DISPLAY PANEL - 1 GALLON Bottle Label

HAND SANITIZER
GEL

Hygeia
pure

INFUSED WITH
ALOE VERA
& GLYCERIN

1 GALLON (128 FL OZ)

70%
ALCOHOL

HAND SANITIZER 70 ALCOHOL 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70956-015
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 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)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70956-015-02	59 mL in 1 TUBE; Type 0: Not a Combination Product	05/21/2020	07/01/2022
2	NDC: 70956-015-04	118 mL in 1 TUBE; Type 0: Not a Combination Product	05/21/2020	07/01/2022
3	NDC: 70956-015-06	200 mL in 1 TUBE; Type 0: Not a Combination Product	05/21/2020	07/01/2022
4	NDC: 70956-015-08	3785.41 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/21/2020	07/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/21/2020	07/01/2022

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(70956-015)

Revised: 9/2022

Document Id: 60972926-1283-4d2a-be08-98042e3ad803

34390-5

Set id: 653b03a6-5ca6-445c-8ddd-93295ab3bd03

Version: 2

Effective Time: 20220914