ASSURE- benzethonium chloride liquid

Drug Labeling and Warnings

Drug Details [pdf]

Active ingredient

Benzethonium chloride 0.2% w/v

Purpose

Antimicrobial

Use

• For hand washing to decrease bacterial on skin.
• Recommended for repeated use.

Warning

For external use only.

When using this product

When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

Stop use and ask a doctor if

Stop use and ask a doctor if irritation or redness develops, or if conditions persist.

Keep out of reach of children

Keep out of reach of children, except under adult supervision. If swallowed, get medical help or contact a Poison Control Center.

Directions

• Hands need not be washed prior to using.
• For one step handwash/antibacterial skin cleaning.
• Place product in palm of hand, add water, work up a lather.
• Rinse hands thoroughly with potable water after washing.

Inactive ingredients

C9-11 Pareth-6; Caprylyl/Capryl Oligpglucoside; Citric acid; DMDM Hydantoin; Dye; Fragrance; Glycerine; Poly(Laurylglucoside)-7; Water.

Questions or comments?

320-693-2477

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INGREDIENTS AND APPEARANCE

ASSURE 
benzethonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63131-1132
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP)	BENZETHONIUM CHLORIDE	2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
DMDM HYDANTOIN (UNII: BYR0546TOW)
C9-11 PARETH-6 (UNII: KCE0V8JT7W)
CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)
GLYCERIN (UNII: PDC6A3C0OX)
POLY(LAURYLGLUCOSIDE)-7 (UNII: VB00RDE21R)
WATER (UNII: 059QF0KO0R)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
BENZYL ALCOHOL (UNII: LKG8494WBH)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63131-1132-1	7570 in 1 CASE	04/17/2007
1		3785 mL in 1 JUG; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/17/2007

Labeler - Anderson Chemical Company (006179220)

Establishment
Name	Address	ID/FEI	Business Operations
Anderson Chemical Company		006179220	manufacture(63131-1132)