Gold Mountain Beauty Fungal Nail Eliminator

Gold Mountain Beauty Fungal Nail Eliminator
SPL v9
SPL
SPL Set ID 6997ce4b-ead8-00bf-e053-2991aa0a6e08
Route
TOPICAL
Published
Effective Date 2018-07-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (0.14 g)
Inactive Ingredients
Thyme Oil Evening Primrose Oil Winter Savory Oil Trimethylpentanediol/adipic Acid/glycerin Crosspolymer (25000 Mpa.s) Olive Oil Hippophae Rhamnoides Fruit Oil Diethylene Glycol Monoethyl Ether Alkyl (c12-15) Benzoate Tea Tree Oil Hippophae Rhamnoides Seed Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2018-07-02

Description

Tolnaftate 1%

Purpose

Antifungal


Medication Information

Warnings and Precautions

Warnings

For external use only

  • Do not use on children under 2 years of age unless directed by a doctor
  • Avoid contact with eyes, ears or mouth
  • If irritation occurs, discontinue use and consult a doctor
  • If swallowed, get medical help or consult a poison control center immediately.
Indications and Usage

Trim nails and file the surface using an emery board

Apply a thin layer of product over affected areas twice daily (morning and night) especially around free edges of nails (under tips) and cuticles and the space around nails

Allow solution to soak into nail or skin

Application to adjacent nails is recommended to prevent the spread of infection

Keep affected areas clean and dry throughout the day

Supervise children in the use of this product

Purpose

Antifungal

Dosage and Administration

Directions

  • Trim nails and file the surface using an emery board
  • Apply a thin layer of product over affected areas twice daily (morning and night) especially around free edges of nails (under tips) and cuticles and the space around nails
  • Allow solution to soak into nail or skin
  • Application to adjacent nails is recommended to prevent the spread of infection
  • Keep affected areas clean and dry throughout the day
  • Supervise children in the use of this product
Description

Tolnaftate 1%

Section 50566-9

  • If irritation occurs, discontinue use and consult a doctor
Section 50569-3

  • If irritation occurs, discontinue use and consult a doctor
Section 51945-4

GOLD MOUNTAIN

Beauty

Foot Therapy

Antifungal

Fungal Nail Eliminator

Section 53413-1

For questions or comments, please visit: goldmountainbeauty.com

Section 60561-8

Other information

Store at room temperature (59 - 86 degrees F)

Active Ingredient

Tolnaftate 1%

Inactive Ingredients

C12-15 Alkyl Benzoate, Ethyldiglycol, Hippophae Rhamnoides (Sea Berry) Fruit Oil, Hippophae Rhamnoides (Sea Berry) Seed Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Olea Europaea (Olive) Oil, Trimethylpentanediol/Adipic Acid Copolymer

For External Use Only

  • Do not use on children under 2 years of age unless directed by a doctor
  • Avoid contact with eyes, ears or mouth
  • If irritation occurs, discontinue use and consult a doctor
  • If swallowed, get medical help or consult a poison control center immediately

Keep Out of Reach of Children

KEEP OUT OF REACH OF CHILDREN


Structured Label Content

Indications and Usage (34067-9)

Trim nails and file the surface using an emery board

Apply a thin layer of product over affected areas twice daily (morning and night) especially around free edges of nails (under tips) and cuticles and the space around nails

Allow solution to soak into nail or skin

Application to adjacent nails is recommended to prevent the spread of infection

Keep affected areas clean and dry throughout the day

Supervise children in the use of this product

Dosage and Administration (34068-7)

Directions

  • Trim nails and file the surface using an emery board
  • Apply a thin layer of product over affected areas twice daily (morning and night) especially around free edges of nails (under tips) and cuticles and the space around nails
  • Allow solution to soak into nail or skin
  • Application to adjacent nails is recommended to prevent the spread of infection
  • Keep affected areas clean and dry throughout the day
  • Supervise children in the use of this product
Warnings and Precautions (34071-1)

Warnings

For external use only

  • Do not use on children under 2 years of age unless directed by a doctor
  • Avoid contact with eyes, ears or mouth
  • If irritation occurs, discontinue use and consult a doctor
  • If swallowed, get medical help or consult a poison control center immediately.
Section 50566-9 (50566-9)

  • If irritation occurs, discontinue use and consult a doctor
Section 50569-3 (50569-3)

  • If irritation occurs, discontinue use and consult a doctor
Section 51945-4 (51945-4)

GOLD MOUNTAIN

Beauty

Foot Therapy

Antifungal

Fungal Nail Eliminator

Section 53413-1 (53413-1)

For questions or comments, please visit: goldmountainbeauty.com

Section 60561-8 (60561-8)

Other information

Store at room temperature (59 - 86 degrees F)

Purpose

Antifungal

Active Ingredient

Tolnaftate 1%

Inactive Ingredients (Inactive ingredients)

C12-15 Alkyl Benzoate, Ethyldiglycol, Hippophae Rhamnoides (Sea Berry) Fruit Oil, Hippophae Rhamnoides (Sea Berry) Seed Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Olea Europaea (Olive) Oil, Trimethylpentanediol/Adipic Acid Copolymer

For External Use Only (For external use only)

  • Do not use on children under 2 years of age unless directed by a doctor
  • Avoid contact with eyes, ears or mouth
  • If irritation occurs, discontinue use and consult a doctor
  • If swallowed, get medical help or consult a poison control center immediately

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

KEEP OUT OF REACH OF CHILDREN


Advanced Ingredient Data


Raw Label Data

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