Nail Renu Antifungal Solution

Nail Renu Antifungal Solution
SPL v1
SPL
SPL Set ID f1877b83-30fc-7c8f-e053-2a95a90a7d1b
Route
TOPICAL
Published
Effective Date 2023-03-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (1 g)
Inactive Ingredients
Ceramide 3 Camphor (natural) Clove Oil Thymol Citronella Oil Clove Tea Tree Oil Cinnamon Bark Oil Trimethylpentanediol/adipic Acid/glycerin Crosspolymer (25000 Mpa.s) Alpha-tocopherol Hippophae Rhamnoides Seed Oil Hippophae Rhamnoides Fruit Oil Oregano Leaf Oil Lavender Oil Limonene, (+)- Alkyl (c12-15) Benzoate Pinene Jojoba Oil Diethylene Glycol Monoethyl Ether Peppermint Oil Olive Oil Almond Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2023-03-22
Description

Purpose Antifungal

Medication Information

Warnings and Precautions

Warnings

  • For external use only.
Indications and 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
Dosage and Administration

Directions

  • clean the affected area and dry thoroughly

    apply a thin layer over the affected area twice daily (morning and night)
Description

Purpose Antifungal

Section 50565-1

KEEP OUT OF REACH OF CHILDREN

Section 50566-9

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.
Section 50567-7
  • When using this product avoid contact with the eyes, nose, and mouth.
Section 50570-1
  • Do not use on children under 2 years of age unless directed by a doctor
Section 51727-6

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

Section 51945-4

Nail RENU LABEL ART

AND

NAIL RENU

BOX ART





Section 53413-1

Questions or Comments

267-482-0866

www.nailrenu.com

Section 53414-9

If Pregnant or breastfeeding ask a health professional before use.

Section 55105-1

Purpose

Antifungal

Section 55106-9

Tolnaftate

Section 59845-8

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.

Section 60561-8

Other information

  • Store at 68º - 77º (20º - 25º C)

Structured Label Content

Indications and Usage (34067-9)

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
Dosage and Administration (34068-7)

Directions

  • clean the affected area and dry thoroughly

    apply a thin layer over the affected area twice daily (morning and night)
Warnings and Precautions (34071-1)

Warnings

  • For external use only.
Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN

Section 50566-9 (50566-9)

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.
Section 50567-7 (50567-7)
  • When using this product avoid contact with the eyes, nose, and mouth.
Section 50570-1 (50570-1)
  • Do not use on children under 2 years of age unless directed by a doctor
Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Nail RENU LABEL ART

AND

NAIL RENU

BOX ART





Section 53413-1 (53413-1)

Questions or Comments

267-482-0866

www.nailrenu.com

Section 53414-9 (53414-9)

If Pregnant or breastfeeding ask a health professional before use.

Section 55105-1 (55105-1)

Purpose

Antifungal

Section 55106-9 (55106-9)

Tolnaftate

Section 59845-8 (59845-8)

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.

Section 60561-8 (60561-8)

Other information

  • Store at 68º - 77º (20º - 25º C)

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:39.190708 · Updated: 2026-03-14T23:01:08.226420