Label: MOLECULAR AF- tolnaftate oil
- NDC Code(s): 76348-401-01, 76348-401-02
- Packager: Renu Laboratories, 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 February 15, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- ASK DOCTOR
- DO NOT USE
- KEEP OUT OF REACH OF CHILDREN
- QUESTIONS
- STOP USE
- STATEMENT OF IDENTITY
- STORAGE AND HANDLING
-
DOSAGE & ADMINISTRATION
Directions:
- clean the affected area and dry thoroughly
- apply a thin layer over the affected area twice daily (morning and night)
- supervise children in the use of the product
- for athlete's foot, pay special attention to the spaces between toes. Wear well-fitting, ventilated shoes, and change shoes and socks at least once daily
- use daily for 4 weeks, if condition lasts longer, ask a doctor
- to prevent athlete's foot, apply to the feet once or twice daily
- this product is not effective on the scalp or nails
- WARNINGS
- INACTIVE INGREDIENT
- INDICATIONS & USAGE
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
MOLECULAR AF
tolnaftate oilProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76348-401 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE 0.01 mg in 1 mL Inactive Ingredients Ingredient Name Strength CINNAMON OIL (UNII: E5GY4I6YCZ) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) ETHYL MACADAMIATE (UNII: ANA2NCS6V1) DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) TEA TREE OIL (UNII: VIF565UC2G) OLIVE OIL (UNII: 6UYK2W1W1E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76348-401-01 11.5 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/01/2011 2 NDC:76348-401-02 11.5 mL in 1 BOX; Type 0: Not a Combination Product 07/01/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M005 07/01/2011 Labeler - Renu Laboratories, Inc. (945739449) Establishment Name Address ID/FEI Business Operations Renu Laboratories, Inc. 945739449 manufacture(76348-401)
