WET WIPES by Dalian Oupai Technology Co.,Ltd.

Drug Details [pdf]

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 Ingredient(s)

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

Do not use

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 Center.

Directions

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

recommended for single use

Inactive ingredients

water(Aqua),Glycerol,Propanediol,Aloe Vera Extrat, 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

PACKAGE

image description

WET WIPES
wet wipes patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78055-009
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
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 (UNII: CUB7JI0JV3)	0.05 g in 100 g
CHLORPHENESIN (UNII: I670DAL4SZ)	0.05 g in 100 g
TOCOPHEROL (UNII: R0ZB2556P8)	0.05 g in 100 g
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)	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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 78055-009-01	50 in 1 PAIL	09/02/2020	09/07/2020
1		6.5 g in 1 PATCH; Type 0: Not a Combination Product
2	NDC: 78055-009-02	70 in 1 PAIL	09/02/2020
2		6.5 g in 1 PATCH; Type 0: Not a Combination Product
3	NDC: 78055-009-03	80 in 1 PAIL	09/02/2020	09/07/2020
3		6.5 g in 1 PATCH; Type 0: Not a Combination Product
4	NDC: 78055-009-04	100 in 1 PAIL	09/02/2020	09/07/2020
4		6.5 g in 1 PATCH; Type 0: Not a Combination Product
5	NDC: 78055-009-05	30 in 1 BAG	09/02/2020	09/07/2020
5		6.5 g in 1 PATCH; Type 0: Not a Combination Product
6	NDC: 78055-009-06	40 in 1 BAG	09/02/2020	09/07/2020
6		6.5 g in 1 PATCH; Type 0: Not a Combination Product
7	NDC: 78055-009-07	50 in 1 BAG	09/02/2020	09/07/2020
7		6.5 g in 1 PATCH; Type 0: Not a Combination Product
8	NDC: 78055-009-08	60 in 1 BAG	09/02/2020	09/07/2020
8		6.5 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	09/02/2020	09/28/2020

Labeler - Dalian Oupai Technology Co.,Ltd. (529342302)

Name	Address	ID/FEI	Business Operations
Establishment
Dalian Oupai Technology Co.,Ltd.		529342302	manufacture(78055-009)

Revised: 9/2020

Document Id: b0589a25-7877-6047-e053-2995a90ade1a

Set id: aeee58e2-f46a-4e6d-ac69-0519abbcd5a5

Version: 4

Effective Time: 20200927