WDC ANTIBACTERIAL TRAVEL WIPES- alcohol and benzalkonium chloride swab
Zhejiang Ruolin Hygienic Products 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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Wipes

Active Ingredient

Ethanol 6%

Benzalkonium Chloride 0.1%

Purpose

Antibacterial

USE

Hand sanitizer to help reduce bacteria on the skin

Warning

For external use only.
Avoid contact with eyes. In case of eye contact, flush eyes with water.

Discontinue use if skin irritation occurs.
This prodduct is not intended for use as a baby wipe.

First Aid:

For advice, contact a Poison Information Centre or a doctor

Do nt use for children under 3 years of age.

If swallowed, get medical help or contact a Poison Contrl Center right away.

Directions

For hands, wipe thoroughly for 1 minute and let dry for 2 minutes.
To disinfect hard surfaces, wipe and let air dry
Do not mix with detergents or other chemicals
After use, dispose of wipes in rubbish bin.
Do not flush wipe down the toilet.

Inactive ingredients

Purified Water, Ethanol, Aloe Vera Barbadensis Extract, Phenoxyethanol, Didecyldimethylammonium Chloride, Glycerin, Ethylhexylglycerin, Propylene Glycol

label image

WDC ANTIBACTERIAL TRAVEL WIPES
alcohol and benzalkonium chloride swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:78823-016
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.10 g in 100 g
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	6 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
water (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:78823-016-01	10 in 1 BAG	07/01/2020
1		4.05 g in 1 POUCH; 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	07/01/2020

Labeler - Zhejiang Ruolin Hygienic Products Co., Ltd. (415426870)

Name	Address	ID/FEI	Business Operations
Establishment
Zhejiang Ruolin Hygienic Products Co., Ltd.		415426870	manufacture(78823-016)