BENZALKONIUM CHLORIDE ANTISEPTIC- benzalkonium chloride swab
Tongzhou Deqi Medical Products Factory

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 Ingredients

Benzalkonium Chloride 0.13%

Purpose

Antiseptic

Use

Prevent infection in minor scrapes

Warnings

For external use only
Flammable,keep away for fire or flame

Do not use:

* In large quantities
* over large areas of the body
* in eyes
* over raw or blistered areas

Stop use and ask a doctor if conditions worsen or persist for more than 7 days or clear up and occur again within a few days.

Keep out of reach of children.if swallowed get medical help or contact Poison control Center right away.

Directions

Adults and Children 2 year and older; Apply to cleaned affected area not more than 3 times daily.
Children under 2 years of age ; Consult a doctor

Inactive Ingredient

Purified Water

BENZALKONIUM CHLORIDE ANTISEPTIC
benzalkonium chloride swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71222-004
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.0013 mg

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71222-004-01	1 in 1 POUCH; Type 0: Not a Combination Product	05/01/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	01/20/2017

Labeler - Tongzhou Deqi Medical Products Factory (544464252)

Name	Address	ID/FEI	Business Operations
Establishment
Tongzhou Deqi Medical Products Factory		544464252	manufacture(71222-004)