Otc - Active Ingredient
Active Ingredient
Tolnaftate 1%
Molecular Af Oil
FDA Label NDC 76348-401
14 label sections · Submitted to the FDA by Renu Laboratories, Llc · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Renu Laboratories, Llc for the product Molecular Af (NDC 76348-401). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, otc - ask doctor, otc - do not use, otc - keep out of reach of children, otc - questions, otc - stop use, statement of identity, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Antifungal
Otc - Ask Doctor
Stop use and ask a doctor if
- there is no improvement within 4 weeks
Otc - Do Not Use
Do not use
- on children under 2 years of age unless directed by a doctor
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Otc - Questions
www.MolecularAF.com
888-919-1818
Otc - Stop Use
Stop use and ask a doctor if
- irritation occurs
- there is no improvement within 4 weeks
Statement Of Identity
Molecular AF
Topical Antifungal System
Dynamic Oil
Storage And Handling
Other information Store at 68° - 77°
(20° - 25° C)
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
Warnings
For external use only
Do not use on children under 2 years of age unless directed by a doctor
When using this product avoid contact with the eyes
Inactive Ingredient
CITRIC ACID MONOHYDRATE, DIETHYLENE GLYCOL MONOETHYL ETHER, ETHYL MACADAMIATE
OLIVE OIL, POTASSIUM SORBATE, TEA TREE OIL
Indications & Usage
Uses proven clinically to cure most:
athlete's foot (tinea pedis)
ringworm (tinea corporis)
effectively soothes and relieves:
itching
burning
cracking
helps prevent most athlete's foot from coming back with daily use
Package Label.Principal Display Panel
This artwork is the peel-back label for Molecular AF.
THE ARTWORK BELOW IS THE BOX PACKAGE FOR MOLECULAR OIL
* Please review the disclaimer below.
