Label: MAXIMUM STRENGTH ANTI FUNGAL TOLNAFTATE 1%- tolnaftate 1% liquid
- NDC Code(s): 0295-9017-07
- Packager: Denison Pharmaceuticals, LLC
- 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 November 3, 2022
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions:
- Clean affected area with soap and warm water and dry thoroughly.
- Apply a thin layer of Fungi-Nail® Anti-Fungal Liquid over affected area twice daily (morning and night) or as directed by a doctor.
- The brush applicator allows for easy application on skin around the nail and cuticle areas.
- Wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.
- For athlete's foot pay special attention to spaces between the toes.
- For athlete's foot and ringworm, use daily for 4 weeks. For toe fungus, apply under nail and around cuticle areas. If condition persists longer, consult a doctor.
- This product is not effective on the scalp or nails.
- Supervise children in the use of this product.
- OTHER SAFETY INFORMATION
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INACTIVE INGREDIENT
Inactive ingredient
Aloe Vera Leaf, Benzoic Acid, Caprylyl Glycol, Carbomer Homopolymer Type A (Allyl Pentaerythritol Crosslinked), Citric Acid, Dimethicone 350, Ethylhexyl Glycerin, Eucalyptol, Glycerin, Glyceryl Monostearate, Lavender Oil, Olive Oil, Phenoxyethanol, Poloxamer 188, Purified Water USP, Sodium Hydroxide, Tea Tree Oil, Triethyl Citrate
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MAXIMUM STRENGTH ANTI FUNGAL TOLNAFTATE 1%
tolnaftate 1% liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0295-9017 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE 1 g in 100 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) DIMETHICONE 350 (UNII: 2Y53S6ATLU) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) EUCALYPTOL (UNII: RV6J6604TK) GLYCERIN (UNII: PDC6A3C0OX) OLIVE OIL (UNII: 6UYK2W1W1E) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLOXAMER 188 (UNII: LQA7B6G8JG) WATER (UNII: 059QF0KO0R) SODIUM HYDROXIDE (UNII: 55X04QC32I) CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: F68VH75CJC) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) LAVENDER OIL (UNII: ZBP1YXW0H8) TEA TREE OIL (UNII: VIF565UC2G) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) BENZOIC ACID (UNII: 8SKN0B0MIM) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0295-9017-07 1 in 1 BOX 07/11/2019 1 30 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 07/11/2019 Labeler - Denison Pharmaceuticals, LLC (001207208) Establishment Name Address ID/FEI Business Operations Denison Pharmaceuticals, LLC 001207208 manufacture(0295-9017)