Label: FORTICEPT ANTIMICROBIAL GEL- benzethonium chloride gel
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Contains inactivated NDC Code(s)
NDC Code(s): 52261-0701-0, 52261-0701-1, 52261-0701-2 - 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 October 27, 2016
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient/Purpose
- WARNINGS
- INDICATIONS & USAGE
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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Directions:
Adults and children 2 years of age and older:
Clean affected area from dirt and debris, let it dry. Apply a thin layer of ForticeptTM Antimicrobial Gel and cover affected area with a clean bandage if needed. Repeat this procedure 1-3 times daily or as needed until condition improves.
Children under 2 years of age: please, consult a doctor
- Storage and handling:
- Inactive ingredients:
- 60g PLPLDP
- 90g PLPLDP
- 120g PLPLDP
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INGREDIENTS AND APPEARANCE
FORTICEPT ANTIMICROBIAL GEL
benzethonium chloride gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52261-0701 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength benzethonium chloride (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) benzethonium chloride 1 g in 1000 g thymol (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E) thymol 1 g in 1000 g Inactive Ingredients Ingredient Name Strength allantoin (UNII: 344S277G0Z) 2 g in 1000 g fd&c blue no. 1 (UNII: H3R47K3TBD) 0.009 g in 1000 g CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) 2.8 g in 1000 g chamomile (UNII: FGL3685T2X) .1 g in 1000 g glycerin (UNII: PDC6A3C0OX) 20 g in 1000 g isohexadecane (UNII: 918X1OUF1E) 3 g in 1000 g LANOLIN (UNII: 7EV65EAW6H) 1.2 g in 1000 g mineral oil (UNII: T5L8T28FGP) 1.6 g in 1000 g petrolatum (UNII: 4T6H12BN9U) 3.6 g in 1000 g polihexanide (UNII: 322U039GMF) 2 g in 1000 g polysorbate 80 (UNII: 6OZP39ZG8H) 0.5 g in 1000 g shea butter (UNII: K49155WL9Y) .8 g in 1000 g sodium acrylate/sodium acryloyldimethyltaurate copolymer (4000000 MW) (UNII: 1DXE3F3OZX) 6.5 g in 1000 g STEARETH-2 (UNII: V56DFE46J5) 1.2 g in 1000 g STEARETH-21 (UNII: 53J3F32P58) 1.2 g in 1000 g water (UNII: 059QF0KO0R) 951.591 g in 1000 g ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK) .1 g in 1000 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52261-0701-0 60 g in 1 TUBE; Type 0: Not a Combination Product 10/27/2016 2 NDC:52261-0701-1 90 g in 1 TUBE; Type 0: Not a Combination Product 10/27/2016 3 NDC:52261-0701-2 120 g in 1 TUBE; Type 0: Not a Combination Product 10/27/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 10/27/2016 Labeler - Cosco International, Inc. (016433141) Registrant - Cosco International, Inc. (016433141) Establishment Name Address ID/FEI Business Operations Cosco International, Inc. 016433141 manufacture(52261-0701) , label(52261-0701) , pack(52261-0701)
