ASSURE- benzethonium chloride liquid 
Anderson Chemical Company

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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Active ingredient

Benzethonium chloride 0.2% w/v

Purpose

Antimicrobial

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

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

Principal Display Panel

Assure label

ASSURE 
benzethonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63131-1132
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63131-1132-17570 in 1 CASE04/17/2007
13785 mL in 1 JUG; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/17/2007
Labeler - Anderson Chemical Company (006179220)
Establishment
NameAddressID/FEIBusiness Operations
Anderson Chemical Company006179220manufacture(63131-1132)

Revised: 5/2020
Document Id: a61ac2f6-f780-6adf-e053-2995a90ad434
Set id: a61ac2f6-f77f-6adf-e053-2995a90ad434
Version: 1
Effective Time: 20200520
 
Anderson Chemical Company