APLICARE ANTISEPTIC PERINEAL WASH II- benzethonium chloride solution 
Aplicare Products, LLC.

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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1617 Aplicare Antiseptic Perineal Wash II

Benzethonium Chloride

  • For external use only
  • Keep out of reach of children
  • Do not apply to broken, irritated or itchy skin
  • Discontinue use immediately if rash, irritation or discomfort develops

  • Antiseptic Perineal Wash

  • water
  • anhydrous citric acid
  • polysorbate 20
  • edetate sodium
  • dmd hydantoin
  • fd&c blue no.1
  • d&c red no. 33
  • sodium hydroxide

  • Questions or comments?
  • 1 800 760-3236 (Monday - Friday 8:30 AM - 5:00 PM EST)

  • Spray perineal wash on skin, pads, linens, clothing and other areas contaminated with waste prior to clean-up to eliminate odor.
  • Remove any bulk waste.
  • Spray additional product on wet cloth to cleanse skinof remaining waste.
  • Wipe with wet cloth and pat dry.

  • Keep Out of Reach of Children

  • Antiseptic perineal wash

Antiseptic Perineal Wash

Antiseptic Perineal Wash


APLICARE ANTISEPTIC PERINEAL WASH II 
benzethonium chloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52380-1617
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE0.2   in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
EDETATE SODIUM (UNII: MP1J8420LU)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52380-1617-260 g in 1 BOTTLE; Type 0: Not a Combination Product02/20/201802/01/2020
2NDC:52380-1617-4120 g in 1 BOTTLE; Type 0: Not a Combination Product02/20/201802/01/2020
3NDC:52380-1617-8240 g in 1 BOTTLE; Type 0: Not a Combination Product02/20/201802/01/2020
4NDC:52380-1617-93785 g in 1 BOTTLE; Type 0: Not a Combination Product02/20/201802/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/01/199802/01/2020
Labeler - Aplicare Products, LLC. (081054904)
Establishment
NameAddressID/FEIBusiness Operations
Aplicare Products, LLC.081054904manufacture(52380-1617)

Revised: 1/2020
Document Id: 9d384d06-081f-8767-e053-2a95a90a5f63
Set id: acf2e81e-5d40-472b-b798-b07e219cb6ef
Version: 4
Effective Time: 20200128
 
Aplicare Products, LLC.