Active Ingredient
Miconazole Nitrate 2%
Molecular Af Molecular Cream
FDA Label NDC 76348-402
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Renu Laboratories, Inc. for the product Molecular Af Molecular Cream (NDC 76348-402). 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 active ingredient, purpose, warnings, otc - keep out of reach of children, otc - stop use, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antifungal
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
Stop use and ask a doctor if
- irritation occurs
- there is no improvement with 4 weeks
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
Keep out of reach of children. If swallowed,
get medical help or contact a Poison Control
Center right away
Otc - Stop Use
Stop use and ask a doctor if
- irritation occurs
- there is no improvement within 4 weeks
Directions
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 this 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
Other Information
- Store at 68° - 77° (20° - 25° C)
Inactive Ingredients
Cetearyl Alcohol, Ceteareth-20, Cinnamonum Verum Oil, Citric Acid, Deionized Water, Emulsifying Wax NF, Ethyl Macadamiate,
Glycerin (Veg.), Melaleuca Alternifolia Oil, Olea Europaea Oil, Origanum Vulgare Oil, Phenoxyethanol, Benzoic Acid,
Dehydroacetic Acid, Propylene Glycol, Trimethylpentanediol / Adipic Acid Copolymer, Vitamin E Acetate, Xanthan Gum
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 this 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, as 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
* Please review the disclaimer below.
