Otc - Purpose
Purpose
Antifungal
Nail Renu
FDA Label NDC 76348-995
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 (NDC 76348-995). 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 - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications & Usage
Uses
- proven clinically to cure most Fungal nail and Skin infections including athlete's foot (tinea pedis) and ringworm (tinea corporis)
- Effectively relieves itching, burning, cracking and scaling associated with the above conditions.
- helps prevent most athlete's foot from coming back with daily use
Warnings
Warnings
- For external use only.
Otc - Do Not Use
- Do not use on children under 2 years of age unless directed by a doctor
Otc - When Using
- When using this product avoid contact with the eyes, nose, and mouth.
Otc - Stop Use
Stop use and ask a doctor if
- irritation occurs
- there is no improvement within 4 weeks
- if swallowed, get medical help or contact a Poison Control Center right away.
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN
Otc - Pregnancy Or Breast Feeding
If Pregnant or breastfeeding ask a health professional before use.
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 intended for/or effective on the scalp.
Other Safety Information
Other information
- Store at 68° - 77° (20° - 25° C)
Otc - Questions
Questions or Comments
267-482-0866
www.nailrenu.com
Inactive Ingredient
Inactive Ingredients
C12-15 Alkyl Benzoate, Camphor, Ceramide III, Cinnamonum Zeylanicum (Cinnamon) Bark Oil, Cymbopogon Nardus (Citronella) Oil, Ethoxydiglycol, Eugenia Caryophyllum (Clove) Bud Extract, Hippophae Rhamnoides (Sea Berry) Fruit and Seed Oils, Lavandula Angustifolia (Lavender) Oil, Limonene, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Mentha piperita (Peppermint) Leaf Oil, Olea Europaea (Olive Pomace) Oil, Oreganum Vulgare (Oregano) Leaf Oil, Pinene, Prunus Amygdallus Dulcis (Sweet Almond) Oil, Simmondsia Chinensis (Jojoba) Oil, Syzgium Aromatique (Clove) Bud Oil, Thymol, Tocopherol (Vitamin E), Trimethylpentanediol-Adipic Acid Copolymer
Dosage & Administration
Directions
- clean the affected area and dry thoroughly
apply a thin layer over the affected area twice daily (morning and night)
Otc - Active Ingredient
Tolnaftate
Package Label.Principal Display Panel
Nail RENU LABEL ART
AND
NAIL RENU
BOX ART
Nailrenu Box (Nailrenuboxapproved 2.16.23)
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