Otc - Active Ingredient
Miconazole Nitrate 2%
Nail Renu Antifungal
FDA Label NDC 76348-997
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 Nail Renu Antifungal (NDC 76348-997). 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, indications & usage, recent major changes, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Antifungal
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
Recent Major Changes
There are no major changes. This is a new submission.
Warnings
For external use only
Otc - When Using
When using this product, avoid contact with the eyes
Otc - Stop Use
Stop use and ask a doctor if
- irritation occurs
- there is no improvement within 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.
Instructions For Use
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
Inactive Ingredient
Benxoic Acid, Ceramide-3, Ceteareth-20, Cetearyl Alcohol, Cinnamomum Zeylanicum (Cinnamon) Bark Oil, Dehydroacetic Acid, Deionized Water, Ethyl Macadamiate, Eucalyptol, Eugenia Caryophyllus (Clove) Bud Oil, Hippophae Rhamnoides (Sea Berry) Fruit and Seed Oils, Melaleuca Alternifolia (Tea Tree) Oil, Olea Europaea (Olive) Fruit Oil, Origanum vulgare (Oregano) Leaf Oil, Propylene Glycol, Thymol, Tocopherol, Triethanolamine, Trimethylpentanediol Adipic Acid Copolymer, Xanthan Gum
Otc - Do Not Use
Do not use on Children under 2 years of age unless directed by a doctor.
Other Safety Information
Other Information
Store at 68° - 77° (20 - 25 C)
Statement Of Identity
NAIL RENU
Miconazole Nitrate 2%
Antifungal Cream
Dosage & Administration
Directions
- Clean the affected area and dry thoroughly
- apply a thin coat over 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, change shoes and socks 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
Package Label.Principal Display Panel
TTUBE ARTWORK AND UNIT BOX ARTWORK FOR NAIL RENU
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