Label: BZK ANTISEPTIC SWAB- benzalkonium chloride swab
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Contains inactivated NDC Code(s)
NDC Code(s): 54429-0103-1, 54429-0103-3, 54429-0103-4, 54429-0103-5 - Packager: Foshan Flying Medical Products Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated May 22, 2016
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- INACTIVE INGREDIENTS
- DIRECTIONS
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WARNINGS
WARNINGS
For external use only.
DO NOT USE, in the eyes. If this happens, rinse thoroughly with water.
STOP USE and ASK A DOCTOR: If irritation or redness develop and persists for more than 72 hours.
CAUTION: Keep out of reach of children
If swallowed, get medical help or contact a Poison Control Center right away. - USES
- CAUTION: Keep out of reach of children
- PURPOSE
- ACTIVE INGREDIENT
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Drug Facts
ACTIVE INGREDIENT
Benzalkonium chloride 0.13% PURPOSE
First Aid Antiseptic USES
Antiseptic cleansing of face, hands and body to decrease bacteria on skin without soap and water. WARNINGS
For external use only.
DO NOT USE, in the eyes. If this happens, rinse thoroughly with water.
STOP USE and ASK A DOCTOR: If irritation or redness develop and persists for more than 72 hours.
CAUTION: Keep out of reach of children
If swallowed, get medical help or contact a Poison Control Center right away. DIRECTIONS
Tear open packet, unfold and use as a washcloth. Allow hands to dry without wiping. OTHER INFORMATION
Store at room temperature. INACTIVE INGREDIENTS
Water.
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INGREDIENTS AND APPEARANCE
BZK ANTISEPTIC SWAB
benzalkonium chloride swabProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54429-0103 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 1.3 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54429-0103-3 12 in 1 CARTON 12/27/2012 1 NDC:54429-0103-1 1.4 mL in 1 PACKET; Type 0: Not a Combination Product 2 NDC:54429-0103-4 21 in 1 CARTON 12/27/2012 2 NDC:54429-0103-1 1.4 mL in 1 PACKET; Type 0: Not a Combination Product 3 NDC:54429-0103-5 100 in 1 CARTON 12/27/2012 3 NDC:54429-0103-1 1.4 mL in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 12/27/2012 Labeler - Foshan Flying Medical Products Co., Ltd. (527021584) Registrant - Foshan Flying Medical Products Co., Ltd. (527021584) Establishment Name Address ID/FEI Business Operations Foshan Flying Medical Products Co., Ltd. 527021584 manufacture(54429-0103)
