Oriental Antibacterial Wipes by Zhejiang Ruolin Hygienic Products Co., Ltd. Wipes

Oriental Antibacterial Wipes by

Drug Labeling and Warnings

Oriental Antibacterial Wipes by is a Otc medication manufactured, distributed, or labeled by Zhejiang Ruolin Hygienic Products Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ORIENTAL ANTIBACTERIAL WIPES- benzalkonium chloride and didecyldimonium chloride swab 
Zhejiang Ruolin Hygienic Products Co., Ltd.

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Wipes

Active Ingredient

Benzalkonium Chloride 0.1%

Didecyldimethylammonium Chloride 0.2%

Purpose

Antibacterial

USE

hand sanitizer to help reduce bacteria on the skin.

Warning

For external use only.

When using this productdo not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop using and ask a doctorif irritation or rash appears and lasts.

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

Directions

• Wet hands thoroughly with product and allow to dry.
• Discard wipes in trash receptacle after use. Do not flush.
• Children under 6 years of age should be supervised when using this product.

Inactive ingredients

Purified Water, Alcohol, Glycerin, Ehtylhexylglycerin, Phenoxyethanol, Propylene Glycol

ORIENTAL ANTIBACTERIAL WIPES 
benzalkonium chloride and didecyldimonium chloride swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78823-022
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.1 g  in 100 g
DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B) (DIDECYLDIMONIUM - UNII:Z7F472XQPA)	DIDECYLDIMONIUM CHLORIDE	0.2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78823-022-01	70 in 1 CANISTER	07/27/2020
1		3.78 g in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 78823-022-02	20 in 1 BAG	07/27/2020
2		4.05 g in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	07/27/2020	11/30/2020

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

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang Ruolin Hygienic Products Co., Ltd.		415426870	manufacture(78823-022)

Revised: 6/2024

Document Id: 1bc29996-af0a-b936-e063-6394a90ab89b

34390-5

Set id: 09511404-00fa-4fce-a1c5-c1d2dc36751b

Version: 2

Effective Time: 20240625

 

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