HAND SANITIZER by Absara Cosmetics S.A.P.I DE C.V. HAND SANITIZER

Drug Details [pdf]

HAND SANITIZER- 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

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 (41ºC). May discolor certain fabrics or surfaces.

Ingredients

Alcohol, Water, Carbomer, Triethanolamine, Glycerin, Propylene Glycol, Aloe Barbadensis Leaf Juice.

Dist. by: Aduro Products LLC, 250 Liberty Street, Metuchen, N.J., 08840

For questions about this product please call: (718) 832 8512

PRINCIPAL DISPLAY PANEL - 250 ml Pouch Label

FRAGRANCE FREE

Herb & Luxe
HAND SANITIZER
RINSE FREE

FORMULATED WITH
70%
ALCOHOL

WITH
ALOE VERA
& GLYCERIN

8.4 FL OZ (250 ml)

Principal Display Panel - 250 ml Pouch Label

HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70956-012
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M)	Alcohol	70 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Carbomer Homopolymer, Unspecified Type (UNII: 0A5MM307FC)
Trolamine (UNII: 9O3K93S3TK)
Glycerin (UNII: PDC6A3C0OX)
Propylene Glycol (UNII: 6DC9Q167V3)
Aloe Vera Leaf (UNII: ZY81Z83H0X)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 70956-012-01	250 mL in 1 POUCH; Type 0: Not a Combination Product	06/09/2020	07/01/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part333A	06/09/2020	07/01/2022

Labeler - Absara Cosmetics S.A.P.I DE C.V. (816161236)

Name	Address	ID/FEI	Business Operations
Establishment
Absara Cosmetics S.A.P.I DE C.V.		816161236	MANUFACTURE(70956-012)

Revised: 9/2022

Document Id: 312528b6-693c-4ff3-b8b1-af7868321945

Set id: c9e7d37c-0de8-4f60-b949-fab7844c12a3

Version: 2

Effective Time: 20220914

Trademark Results [HAND SANITIZER]

Mark Image Registration \| Serial	Company Trademark Application Date
HAND SANITIZER 88958909 not registered Live/Pending	MAISON BLANCHE, LLC 2020-06-10