Signature Black Bottle Tea Tree Antifungal Foot & Body Wash

Signature Black Bottle Tea Tree Antifungal Foot & Body Wash
SPL v4
SPL
SPL Set ID 2c966d97-30f5-4942-b64d-742884ce6a2f
Route
TOPICAL
Published
Effective Date 2016-02-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (10 mg)
Inactive Ingredients
Water Coco Monoethanolamide Cocamidopropyl Betaine Disodium Oleamido Monoethanolamine Sulfosuccinate Panthenol Dmdm Hydantoin Glycol Stearate Isopropyl Myristate Tea Tree Oil Peppermint Oil Oregano Leaf Oil Sodium Laureth Sulfate Sodium Lauryl Sulfate Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-02-10

Description

Tolnaftate 1.0%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Tolnaftate 1.0%

Uses
  • Proven clinically effective in the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis)
  • Helps prevent most athlete's foot with daily use
  • For effective relief of itching, burning and cracking
Purpose:

Antifungal

Warnings

For external use only

Directions
  • Wash affected area and dry thoroughly
  • Apply a thin layer over affected area twice daily (morning and night) or as directed by a doctor
  • Supervise children in the use of this product
  • For athlete's foot: pay special attention to the spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily
  • Use daily for 4 weeks; if condition persists longer, ask a doctor
  • Prevent athlete's foot, apply once or twice daily (morning and/or night
  • This product is not effective on the scalp or nails
Do Not Use

on children under 2 years of age except under the advice and supervision of a doctor

Other Information

Store between 20° to 25°C (68° to 77°F)

Package Labeling:

Active Ingredients:

Tolnaftate 1.0%

Inactive Ingredients:

Acrylates copolymer, aqua (deionized water), cocamide MEA, cocamidopropyl betaine, disodium oleamido MEA sulfosuccinate, dl-panthenol, DMDM hydantoin, glycol stearate, isopropyl myristate, melaleuca alternifolia (australian tea tree) leaf oil, mentha piperita (peppermint) oil, origanum vulgare (oregano) leaf oil, sodium laureth sulfate, sodium lauryl sulfate, triethanolamine.

When Using This Product

avoid contact with the eyes

Stop Use and Ask A Doctor If:
  • Irritation occurs
  • There is no improvement within 4 weeks
Keep Out of Reach of Children.

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


Structured Label Content

Uses
  • Proven clinically effective in the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis)
  • Helps prevent most athlete's foot with daily use
  • For effective relief of itching, burning and cracking
Purpose:

Antifungal

Warnings

For external use only

Directions
  • Wash affected area and dry thoroughly
  • Apply a thin layer over affected area twice daily (morning and night) or as directed by a doctor
  • Supervise children in the use of this product
  • For athlete's foot: pay special attention to the spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily
  • Use daily for 4 weeks; if condition persists longer, ask a doctor
  • Prevent athlete's foot, apply once or twice daily (morning and/or night
  • This product is not effective on the scalp or nails
Do Not Use (Do not use)

on children under 2 years of age except under the advice and supervision of a doctor

Other Information (Other information)

Store between 20° to 25°C (68° to 77°F)

Package Labeling:

Active Ingredients: (Active ingredients:)

Tolnaftate 1.0%

Inactive Ingredients: (Inactive ingredients:)

Acrylates copolymer, aqua (deionized water), cocamide MEA, cocamidopropyl betaine, disodium oleamido MEA sulfosuccinate, dl-panthenol, DMDM hydantoin, glycol stearate, isopropyl myristate, melaleuca alternifolia (australian tea tree) leaf oil, mentha piperita (peppermint) oil, origanum vulgare (oregano) leaf oil, sodium laureth sulfate, sodium lauryl sulfate, triethanolamine.

When Using This Product (When using this product)

avoid contact with the eyes

Stop Use and Ask A Doctor If: (Stop use and ask a doctor if:)
  • Irritation occurs
  • There is no improvement within 4 weeks
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.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)