HAND SANITIZER- benzethonium chloride gel 
RIMPORTS INC.

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 0.105%

Purpose

Antiseptic

Stop use and ask a doctor if redness appears and persists for more than 72 hours.

KEEP OUT OF REACH OF CHILDREN. If swallowed, contact medical help or poison control.

Directions Spray on palm and rub your hands together until absorbed.

Inactive Ingredients

Water, PEG-40 Hydrogenated Castor Oil, Betaine, Fragrance, Citrus Aurantium Dulcis (Orange) Peel Oil, Zingiber Offincinale (Ginger) Root Oil,, Phenoxyethanol, Diazolidinyl Urea, Palmitamidopropyltrimonium Chloride, Sodium Citrate, Disodium EDTA.

Other Information

May damage fabrics and surfaces.

Uses

For waterless hand washing to decrease bacteria on skin. Recommended for repeated use.

WARNINGS:

For external use only.

When using this product, Avoid face, eyes or sensitive areas. If contact occurs flush thoroughly with water.

image of bottle label

HAND SANITIZER 
benzethonium chloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72131-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE0.105 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
BETAINE (UNII: 3SCV180C9W)  
CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T)  
ZINGIBER OFFICINALE WHOLE (UNII: IN6Q3S3414)  
WATER (UNII: 059QF0KO0R)  
PALMITAMIDOPROPYLTRIMONIUM CHLORIDE (UNII: N2U96D202F)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72131-003-0159 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/06/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/06/2018
Labeler - RIMPORTS INC. (361320844)

Revised: 3/2018
Document Id: 676f6d45-5641-8c7b-e053-2991aa0a1b41
Set id: 676f6d45-5640-8c7b-e053-2991aa0a1b41
Version: 1
Effective Time: 20180315
 
RIMPORTS INC.