FAMOLOGY ANTIBACTERIAL WIPES- 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

Benzalkonium Chloride 0.1%

Purpose

Antibacterial

USE

Hand sanitizer to help reduce bacteria on the skin.

Warning

For external use only.

When using this product do not use in or near the eyes. In case of contact rinse eyes toroughly withh water.

Stop use and ask a Doctor if irritation or rash appears and lasts.

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

Directions

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

Inactive ingredients

Water, Glycerin, Ehtylhexylglycerin, Phenoxyethanol, Propylene Glycol, Didecydimonium Chloride, Alcohol, Propvlene glycol

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FAMOLOGY ANTIBACTERIAL WIPES
benzalkonium chloride swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:78823-024
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

Ingredient Name	Strength
Inactive Ingredients
water (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)
ALCOHOL (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:78823-024-01	70 in 1 CANISTER	08/03/2020
1		3.78 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	06/12/2020

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

Name	Address	ID/FEI	Business Operations
Establishment
Zhejiang Ruolin Hygienic Products Co., Ltd.		415426870	manufacture(78823-024)