BACTRO DISINFECTING WIPE- benzalkonium chloride swab
JIANGMEN SHUIZIRUN SANITARY ARTICLES 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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DRUG FACTS

Active Ingredient

Benzalkonium Chloride .......... 0.13 %

Purpose

Antiseptic cleanser

Uses:

Apply topically as needed as cleanse

Warnings

For external use on hands only. Stop use and ask a doctor if irritation develops.

Store and handling

Store in a cool place.

Keep out of reach of children.

if swallowed get medical help or contact a Poison Control Center right away.

Directions

apply to skin as needed. Discard after single use.

Inactive Ingredients:

Glycerol,1,2-propanediol, 2-phenoxyetanol, Didecyl dimethyl ammonium chloride, 2-propandiol, Antibacterial synerists, Stabilizer, Water

Principal Display Panel

BACTRO DISINFECTING WIPE
benzalkonium chloride swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71734-313
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
water (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71734-313-01	3.7 g in 1 PACKAGE; Type 0: Not a Combination Product	07/10/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	07/10/2020

Labeler - JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD. (544530534)

Name	Address	ID/FEI	Business Operations
Establishment
JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.		544530534	MANUFACTURE(71734-313)