CPAP WIPES- cpap wipes cloth 
Shenzhen Shierjie Biological Engineering Co., LTD

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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43116-031
CPAP WIPES

Active Ingredient


Phenoxyethanol 0.3%

Purpose


Cleaning

Uses

CPAP WIPES to help to clean and reduce bacteria that potentially can cause disease.
For use when soap and water are not available.

Warnings

For external use only.

Do not use

On children less than 2 months of age
On open skin wounds

When using this product

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if


Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children


Kep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions


Wipe your CPAP Mask after each use and discard the wipe after cleaning. Let CPAP mask air dry. Keep cover closed in between uses to prevent drying. If irritation occurs discontinue use and seek medical advice. Store in a cool dry place.

Other information

-N/A

Inactive ingredients

DMDMH, Water (Aqua)

43116-031-01

CPAP WIPES 
cpap wipes cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43116-031
Route of AdministrationCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENOXYETHANOL (UNII: HIE492ZZ3T) (PHENOXYETHANOL - UNII:HIE492ZZ3T) PHENOXYETHANOL0.3 g  in 100 
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
HYDANTOIN (UNII: I6208298TA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43116-031-0170 in 1 PACKET; Type 0: Not a Combination Product08/04/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other08/04/2023
Labeler - Shenzhen Shierjie Biological Engineering Co., LTD (547610261)
Registrant - Shenzhen Shierjie Biotech Co .,LTD (547610261)
Establishment
NameAddressID/FEIBusiness Operations
Shenzhen Shierjie Biological Engineering Co., LTD547610261manufacture(43116-031)

Revised: 8/2023
Document Id: 020f8beb-46c7-2b1b-e063-6394a90a1d2f
Set id: 020f8bd6-21ac-0732-e063-6394a90a125e
Version: 1
Effective Time: 20230803
 
Shenzhen Shierjie Biological Engineering Co., LTD