Label: FORTICEPT ANTIFUNGAL BALM- tolmaftate liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 52261-0100-0, 52261-0100-1 - Packager: Cosco International, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 11, 2016
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- Official Label (Printer Friendly)
- Active Ingredient/Purpose
- Warnings
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Directions
- Read all package directions and warnings before use. Use only as directed.
- Clean the affected area with soap and warm water and dry thoroughly.
- Apply a thin layer of FORTICEPTTM COOLING BALM over the affected area twice daily (morning and night), or as directed by a doctor.
- For athlete's foot, pay special attention to spaces between toes; wear well fitting, ventilated shoes, and change shoes and socks at least once daily.
- For athlete's foot and ringworm, use daily for 4 weeks. If condition persists longer, consult a doctor.
- Intended for use by normally healthy individuals only.
- Persons under 18 years of age or those with highly sensitive or allergic skin should use only as directed by a doctor.
- Supervise children in the use of this product.
- SPL UNCLASSIFIED SECTION
- Inactive ingredients:
- 30g
- 60g
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INGREDIENTS AND APPEARANCE
FORTICEPT ANTIFUNGAL BALM
tolmaftate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52261-0100 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength tolnaftate (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) tolnaftate 10 g in 1000 g Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) 415.7 g in 1000 g sunflower oil (UNII: 3W1JG795YI) 158.225 g in 1000 g dimethicone (UNII: 92RU3N3Y1O) 150 g in 1000 g DIHEPTYL SUCCINATE (UNII: 057N7SS26Y) 80 g in 1000 g glyceryl monostearate (UNII: 230OU9XXE4) 65 g in 1000 g GLYCERYL DIBEHENATE (UNII: R8WTH25YS2) 50 g in 1000 g peg-40 castor oil (UNII: 4ERD2076EF) 25 g in 1000 g polyglyceryl-10 oleate (UNII: 55C81W76DH) 24.675 g in 1000 g POLIHEXANIDE HYDROCHLORIDE (UNII: 4XI6112496) 10 g in 1000 g methyl lactate, (-)- (UNII: 0379G9C44S) 4 g in 1000 g tea tree oil (UNII: VIF565UC2G) 2.5 g in 1000 g eucalyptus oil (UNII: 2R04ONI662) 1.8 g in 1000 g GLYCERYL CAPRATE (UNII: 197M6VFC1W) 1.05 g in 1000 g ACACIA DECURRENS FLOWER (UNII: 8PHF3LSM61) 1.05 g in 1000 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52261-0100-0 30 g in 1 TUBE; Type 0: Not a Combination Product 05/04/2016 2 NDC:52261-0100-1 60 g in 1 TUBE; Type 0: Not a Combination Product 05/04/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 05/04/2016 Labeler - Cosco International, Inc. (016433141) Registrant - Cosco International, Inc. (016433141) Establishment Name Address ID/FEI Business Operations Cosco International, Inc. 016433141 manufacture(52261-0100) , label(52261-0100) , pack(52261-0100)
