Label: NOVONAIL SOLUTION- tolnaftate 1% liquid
- NDC Code(s): 72839-507-01
- Packager: Derma Care Research Labs, 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 July 24, 2023
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
For athlete's foot and ringworm: use daily for 4 weeks. Clean the affected area and dry thoroughly. Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor. Supervise children in the use of this product. This product is not effective for the treatment of ringworm of the scalp or nails. For athlete's foot: pay special attention to spaces between the toes, wear well-fitting, ventilated shoes, and change shoes and socks at least once daily. To prevent athlete's foot, apply once or twice daily (morning and/or night). Apply to skin around the nail and cuticle.
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INACTIVE INGREDIENT
Aloe Barbadensis Leaf Extract, BHT, Carthamus Tinctorius (Safflower) Seed Oil, Hydrogenated Polyisobutene, Lavandula Angustifolia (Lavender) Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Sesamum Indicum (Sesame) Seed Oil, Oryza Sativa (Rice) Bran Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Tocopheryl Acetate.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
NOVONAIL SOLUTION
tolnaftate 1% liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72839-507 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 HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) ALMOND OIL (UNII: 66YXD4DKO9) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ALOE VERA LEAF (UNII: ZY81Z83H0X) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL (UNII: VIF565UC2G) RICE BRAN OIL (UNII: LZO6K1506A) SAFFLOWER OIL (UNII: 65UEH262IS) LAVENDER OIL (UNII: ZBP1YXW0H8) JOJOBA OIL (UNII: 724GKU717M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72839-507-01 13.3 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 03/11/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M005 03/11/2020 Labeler - Derma Care Research Labs, LLC (116817470) Registrant - Derma Care Research Labs, LLC (116817470) Establishment Name Address ID/FEI Business Operations Derma Care Research Labs, LLC 116817470 manufacture(72839-507)