Label: FLORASEPTIC WOUND GEL- benzethonium chloride, allantoin gel
- NDC Code(s): 82910-0602-1
- Packager: BonePharm, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated June 30, 2024
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- 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
-
INGREDIENTS AND APPEARANCE
FLORASEPTIC WOUND GEL
benzethonium chloride, allantoin gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82910-0602 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:82910-0602-1 0.0850 kg in 1 TUBE; Type 0: Not a Combination Product 06/30/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M003 06/30/2024 Labeler - BonePharm, LLC (086367335) Registrant - BonePharm, LLC (086367335) Establishment Name Address ID/FEI Business Operations Cosco International, Inc. 016433141 manufacture(82910-0602) , label(82910-0602) , pack(82910-0602)