HAND SANITIZER NON-ALCOHOL- benzethonium liquid
Delon Laboratories (1990) Ltd

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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Drug Facts

Active Ingredient / Purpose

Benzethonium Chloride (0.2% W/W)

Uses

Hand Sanitizer which kills harmful bacteria or germs.
Use as needed as part of your daily cleansing routine.
Children under 6 years of age should be supervised when using this product.

Directions

Apply liberally to the palm of one hand and rub hands together until hands are dry. Rub the product over all surfaces of hands and fingers as part of your daily cleansing routine.

Inactive Ingredients

Aqua (Water), PEG-40 Hydrogenated Castor Oil, Glycerin, Parfum*

*with Fragrance only.

Purpose

Antiseptic

Keep out of reach of children.

Children under 6 years of age should be supervised when using this product.

Warnings

For external use only.
Store between 59 and 86F.
Avoid contact with eyes. If contact occurs, flush eyes thoroughly with water. Discontinue use and consult a physician if irritation develops or increases.
In case of accidental ingestion contact your physician or a Poison Control Centre.

use as needed

label mm1

HAND SANITIZER NON-ALCOHOL
benzethonium liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61734-102
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP)	BENZETHONIUM CHLORIDE	0.2 mg in 100 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:61734-102-01	7 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	05/20/2010	12/03/2014
2	NDC:61734-102-02	8 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	05/20/2010	12/03/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	05/20/2010	12/03/2014

Labeler - Delon Laboratories (1990) Ltd (248364184)

Name	Address	ID/FEI	Business Operations
Establishment
Delon Laboratories (1990) Inc.		243387722	manufacture(61734-102) , pack(61734-102) , label(61734-102)

Revised: 9/2016

Document Id: 3ce16b2c-595a-2a45-e054-00144ff8d46c

Set id: 4476216d-0dbb-4155-b73c-a1507092de0c

Version: 11

Effective Time: 20160919

Delon Laboratories (1990) Ltd