CPAP MASK CLEANING WIPES- benzethonium chloride and benzalkonium chloride cloth 
JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.

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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DRUG FACTS

Active Ingredient

Benzethonium Chloride 0.03%

Benzalkonium Chloride 0.02%

Purpose

Antiseptic and antifungal

Uses:

Removes oil ,dirt and grime from your CPAP mask,prepping your mask for daily cleaning with activated oxygen.

For external use only.

  • for external use only.
  • do not use in eyes. If this occurs, rinse thoroughly with water.
  • Stop use and ask a doctor if irritation o redness develops and persists for more than 72 hours.

Keep out of reach of children.

if swallowed get medical help or contact a Poison Control Center right away.

Directions

Removes oil ,dirt and grime from your CPAP mask,prepping your mask for daily cleaning with activated oxygen.

Inactive Ingredients:

Purified water, Sodium Dehydroacetate, Organic Silicon Defoamer, Citric Acid

Principal Display Panel

CPAP MASK CLEANING WIPES 
benzethonium chloride and benzalkonium chloride cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71734-212
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE0.03 g  in 1 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.02 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71734-212-011.2 g in 1 PACKAGE; Type 0: Not a Combination Product06/07/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/07/2019
Labeler - JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD. (544530534)
Registrant - JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD. (544530534)
Establishment
NameAddressID/FEIBusiness Operations
JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.544530534MANUFACTURE(71734-212)

Revised: 6/2019
Document Id: 4744ddbf-e7d3-4c7b-ae04-b11cc6516fb1
Set id: 412e6fec-5af5-45f7-8c6b-393b884e161c
Version: 1
Effective Time: 20190607
 
JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.