WET WIPES- wet wipes patch 
Dalian Oupai 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 Ingredients

Benzalkonium Chloride 0.13%  . Purpose: Antiseptic/Hand & Skin Sanitizer

Do not use in ears,eyes or mouth.

USES Sanitizing Hand Wipes to help decrease bacteria on the skin.Recommended for single use.

Stop use and ask a doctor if redness or irritation develop and persist for more than 72 hours.

Keep out of reach of children.

If swallowed, get medical help or contact Poison Control Centre immediately.

DIRECTIONS FOR USE:

Wipe liberally over the hands & body,rub into skin until dry.

Recommended for single use.

Inactive ingredients

Water(Aqua),Glycerol,Propanediol,Aloe Vera Extract, Amino acid moisturizer,Hexadecylpyridinium Chloride,Chlorphenesin,Vitamin E,Dodecyl polyglucoside,Citric acid,Sodium citrate.

Purpose

Antiseptic/hand & Skin sanitizer

USES

USES Sanitizing Hand Wipes to help decrease bacteria on the skin.Recommeded for single use.

WARNING

Do not freeze.For external use only,Store at room temperature.

Do not use in ears,eyes or mouth.

Avoid contact with the eyes.In case of contact,flush eyes with water.

Stop use and ask a doctor if redness or irritation develop and persist for more than 72 hours.

Keep out of reach of children.

Children should be supervised when using this product.

If swallowed, get medical help or contact Poison Control Centre immediately.

image description

WET WIPES 
wet wipes patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78055-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 g  in 100 g
WATER (UNII: 059QF0KO0R) 98.73 g  in 100 g
PROPANEDIOL (UNII: 5965N8W85T) 0.2 g  in 100 g
ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.1 g  in 100 g
BETAINE (UNII: 3SCV180C9W) 0.1 g  in 100 g
CETYLPYRIDINIUM CHLORIDE ANHYDROUS (UNII: 6BR7T22E2S) 0.05 g  in 100 g
CHLORPHENESIN (UNII: I670DAL4SZ) 0.05 g  in 100 g
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) 0.05 g  in 100 g
POLY(LAURYLGLUCOSIDE)-7 (UNII: VB00RDE21R) 0.05 g  in 100 g
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 0.02 g  in 100 g
SODIUM CITRATE (UNII: 1Q73Q2JULR) 0.02 g  in 100 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78055-010-0170 in 1 PAIL09/28/2020
16.5 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 finalpart333A09/28/2020
Labeler - Dalian Oupai Technology Co.,Ltd. (529342302)
Establishment
NameAddressID/FEIBusiness Operations
Dalian Oupai Technology Co.,Ltd.529342302manufacture(78055-010)

Revised: 10/2020
Document Id: b15d1d12-ecb6-9697-e053-2a95a90a8396
Set id: aa2a15d6-f8d5-4b90-8218-8bca7b45c4d8
Version: 3
Effective Time: 20201010
 
Dalian Oupai Technology Co.,Ltd.