Label: FLORASEPTIC WOUND GEL- benzethonium chloride, allantoin gel
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Contains inactivated NDC Code(s)
NDC Code(s): 52261-0602-1 - Packager: Cosco International, Inc.
- 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 June 30, 2022
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- DRUG FACTS
- Uses:
- Warnings:
- Do not use:
- Ask a doctor before use if you have:
- When using this product:
- Stop use and ask a doctor if:
- KEEP OUT OF REACH OF CHILDREN
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Directions:
Adults and children 2 years of age and older:
• Clean minor cut, scrapes, or burns by thoroughly flushing the affected area with water or a wound cleanser and let air dry
• Apply appropriate layer of the gel to cover the affected area
• Cover with adhesive bandage or sterile gauze if needed
• Apply 1 to 3 times daily
• Children under 2 years of age: ask a doctor - Inactive Ingredients:
- Storage and handling:
- For Questions:
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FLORASEPTIC WOUND GEL
benzethonium chloride, allantoin gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52261-0602 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE 0.0012 kg in 1 kg ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN 0.0050 kg in 1 kg Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) HYDROLYSED BOVINE COLLAGEN (ENZYMATIC; 2000-5000 MW) (UNII: 5WE8P977RQ) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) ALCOHOL (UNII: 3K9958V90M) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLYCERIN (UNII: PDC6A3C0OX) HYDRASTIS CANADENSIS WHOLE (UNII: R763EBH88T) LAURETH-7 (UNII: Z95S6G8201) PANAX QUINQUEFOLIUS WHOLE (UNII: 0P067WOA1X) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S) (UNII: 5F4963KLHS) HYALURONATE SODIUM (UNII: YSE9PPT4TH) SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52261-0602-1 0.0850 kg in 1 TUBE; Type 0: Not a Combination Product 07/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 07/01/2022 Labeler - Cosco International, Inc. (016433141) Registrant - Cosco International, Inc. (016433141) Establishment Name Address ID/FEI Business Operations Cosco International, Inc. 016433141 manufacture(52261-0602) , label(52261-0602) , pack(52261-0602)
