Nail Renu Antifungal Cream

Nail Renu Antifungal Cream
SPL v1
SPL
SPL Set ID 003d6dd9-f805-3185-e063-6394a90afc94
Route
TOPICAL
Published
Effective Date 2023-07-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (0.6 g)
Inactive Ingredients
Polyoxyl 20 Cetostearyl Ether Water Eucalyptol Clove Oil Hippophae Rhamnoides Seed Oil Melaleuca Alternifolia (tea Tree) Leaf Oil Oregano Leaf Oil Hippophae Rhamnoides Fruit Oil Propylene Glycol Thymol Tocopherol Xanthan Gum Olive Oil Benzoic Acid Cetostearyl Alcohol Cinnamon Bark Oil Dehydroacetic Acid Ethyl Macadamiate Ceramide 3 Trolamine Trimethylpentanediol/adipic Acid/glycerin Crosspolymer (25000 Mpa.s)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2023-07-17

Description

Miconazole Nitrate 2%


Medication Information

Warnings and Precautions

For external use only

Indications and 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

Dosage and 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
Description

Miconazole Nitrate 2%

Section 43683-2

There are no major changes. This is a new submission.

Section 50565-1

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 4 weeks
Section 50567-7

When using this product, avoid contact with the eyes

Section 50570-1

Do not use on Children under 2 years of age unless directed by a doctor.

Section 51727-6

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

Section 51945-4

TTUBE ARTWORK AND UNIT BOX ARTWORK FOR NAIL RENU

Section 55105-1

Antifungal

Section 55106-9

Miconazole Nitrate 2%

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 effective on the scalp or nails
Section 60561-8

Other Information

Store at 68º - 77º (20 - 25 C)

Section 69718-5

NAIL RENU

Miconazole Nitrate 2%

Antifungal Cream


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

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
Warnings and Precautions (34071-1)

For external use only

Section 43683-2 (43683-2)

There are no major changes. This is a new submission.

Section 50565-1 (50565-1)

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 4 weeks
Section 50567-7 (50567-7)

When using this product, avoid contact with the eyes

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)

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

Section 51945-4 (51945-4)

TTUBE ARTWORK AND UNIT BOX ARTWORK FOR NAIL RENU

Section 55105-1 (55105-1)

Antifungal

Section 55106-9 (55106-9)

Miconazole Nitrate 2%

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 effective on the scalp or nails
Section 60561-8 (60561-8)

Other Information

Store at 68º - 77º (20 - 25 C)

Section 69718-5 (69718-5)

NAIL RENU

Miconazole Nitrate 2%

Antifungal Cream


Advanced Ingredient Data


Raw Label Data

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