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

HAND SANITIZER by

Drug Labeling and Warnings

HAND SANITIZER 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- alcohol liquid 
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

Alcohol 80% v/v

Purpose

Antiseptic

Use(s)

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable.

Keep away from heat or flame.

Do not use

• - In children less than 2 months of age.
• - On open skin wounds.

When using this product keep out of eyes, ears, and mouth.

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

Stop use and ask doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• - Place enough product on hands to cover all surfaces.
  Rub hands together until dry.
• - Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

• - Store between 15-30C (59-86F)
• - Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

Glycerin, hydrogen peroxide, purified water USP.

Questions or Comments?

1-800-615-3191 cloralen@alenusa.com, or visit: www.cloralen.com

DISTRIBUTED BY:
ALEN USA
Houston, TX
77040 USA

PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label

LIQUID HAND SANITIZER

CLORALEN™
HAND SANITIZER

ALCOHOL
ANTISEPTIC
80%

TOPICAL
SOLUTION

NON
STERILE
SOLUTION

2.03 FL OZ (60 mL)

TRAVEL SIZE

HAND SANITIZER 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70956-013
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M)	Alcohol	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70956-013-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/09/2020	07/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part333A	06/09/2020	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(70956-013)

Revised: 9/2022

Document Id: c26c8f3d-e9cb-4025-813b-aada3aa8d3ac

34390-5

Set id: e058e573-9091-4dd0-9b13-44a712ca3901

Version: 4

Effective Time: 20220914