WET WIPES- wet wipes cloth 
Shandong Tricol Marine Biological Technology 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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Active Ingredient(s)

Benzethonium chloride 0.03% （w/w）

Purpose

Antiseptic

Use

to help reduce bacteria on the skin.

for use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

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 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.

Directions

Tear the packaging at the zigzag edge to use

Other information

Inactive ingredients

Water,Cetylpyridinium chloride anhydrous,Chlorphenesin,Propylene glycol,Phenoxyethanol,Ethylhexylglycerin,Phrithione Sodium

Package Label - Principal Display Panel

package label

WET WIPES 
wet wipes cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54156-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE0.03 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
PYRITHIONE SODIUM (UNII: 6L3991491R)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
WATER (UNII: 059QF0KO0R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CETYLPYRIDINIUM CHLORIDE ANHYDROUS (UNII: 6BR7T22E2S)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54156-002-0124 in 1 PACKET11/20/2020
10.03 g in 1 PATCH; Type 0: Not a Combination Product
2NDC:54156-002-0220 in 1 PACKET11/20/2020
20.03 g in 1 PATCH; Type 0: Not a Combination Product
3NDC:54156-002-0310 in 1 PACKET11/20/2020
30.03 g in 1 PATCH; Type 0: Not a Combination Product
4NDC:54156-002-0448 in 1 PACKET11/20/2020
40.03 g in 1 PATCH; Type 0: Not a Combination Product
5NDC:54156-002-0596 in 1 PACKET11/20/2020
50.03 g in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E11/20/2020
Labeler - Shandong Tricol Marine Biological Technology Co.,Ltd (541569370)
Establishment
NameAddressID/FEIBusiness Operations
Shandong Tricol Marine Biological Technology Co.,Ltd541569370manufacture(54156-002)

Revised: 1/2021
Document Id: ba041c05-10a2-0bc7-e053-2995a90aa36c
Set id: b4843900-6628-8f66-e053-2a95a90a1c00
Version: 3
Effective Time: 20210129
 
Shandong Tricol Marine Biological Technology Co.,Ltd