1617 Aplicare Antiseptic Perineal Wash II

Aplicare Antiseptic Perineal Wash II by

Drug Labeling and Warnings

Aplicare Antiseptic Perineal Wash II by is a Otc medication manufactured, distributed, or labeled by Aplicare Products, LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

APLICARE ANTISEPTIC PERINEAL WASH II 
benzethonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52380-1617
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52380-1617-2	60 g in 1 BOTTLE; Type 0: Not a Combination Product	02/20/2018	02/01/2020
2	NDC: 52380-1617-4	120 g in 1 BOTTLE; Type 0: Not a Combination Product	02/20/2018	02/01/2020
3	NDC: 52380-1617-8	240 g in 1 BOTTLE; Type 0: Not a Combination Product	02/20/2018	02/01/2020
4	NDC: 52380-1617-9	3785 g in 1 BOTTLE; Type 0: Not a Combination Product	02/20/2018	02/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/01/1998	02/01/2020

Labeler - Aplicare Products, LLC. (081054904)

Establishment
Name	Address	ID/FEI	Business Operations
Aplicare Products, LLC.		081054904	manufacture(52380-1617)

Revised: 1/2020

Document Id: 9d384d06-081f-8767-e053-2a95a90a5f63

34390-5

Set id: acf2e81e-5d40-472b-b798-b07e219cb6ef

Version: 4

Effective Time: 20200128

 

Aplicare Products, LLC.