Dermatin Antifungal

Dermatin Antifungal
SPL v7
SPL
SPL Set ID e993fa3b-1d85-46b7-bda5-ed875be74c4e
Route
TOPICAL
Published
Effective Date 2011-02-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (0.01 g)
Inactive Ingredients
Carbomer Copolymer Type A (allyl Pentaerythritol Crosslinked) Alcohol Cetyl Alcohol Dimethicone Glyceryl Stearate Se Peg-100 Stearate Propylene Glycol Steareth-2 Steareth-21 Stearic Acid Tea Tree Oil Water Trolamine Benzyl Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-01-01

Description

Active ingredients Clotrimazole 1%


Medication Information

Warnings and Precautions

Warnings

For external use only

  • When using this product avoid contact with the eyes

Indications and Usage

Uses

  • Cures most athlete's foot, jock itch, and ringworm
  • Relieves itching, burning, cracking, scaling, and discomfort accompanying these conditions

Dosage and Administration

Directions

  • clean the affected area and dry thoroughly
  • apply a thin layer of the product over the affected area twice daily (morning and night) or as directed by a physician
  • children under 12 years of age should be supervised in the use of this product
  • for athlete's foot: pay special attention to spaces between the toes: wear well-fitting, ventilated shoes: change shoes and socks at least once daily
  • for athletes foot and ringworm, use daily for 4 weeks: for jock itch, use daily for 2 weeks
  • this product is not effective on scalp or nails

Description

Active ingredients Clotrimazole 1%

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 (for athlete's foot and ringworm) or 2 weeks (for jock itch)

Section 50570-1

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

Section 51727-6

Other ingredients  Water, T36 C5 Melaleuca Oil, Stearic Acid, Cetyl alcohol, SD Alcohol 40B, Glyceryl Stearate and PEG 100 Stearate, Steareth 21, Propylene Glycol, Dimethicone, Acrylates/C10-30 Alkylacrylates Crosspolymer, Triethanolamine, Steareth 2, Benzyl Alcohol, Methylsothiazolinone, BHT.

Section 51945-4

Section 55105-1

Purpose

Antifungal

Section 55106-9

Active ingredients

Clotrimazole 1%


Structured Label Content

Indications and Usage (34067-9)

Uses

  • Cures most athlete's foot, jock itch, and ringworm
  • Relieves itching, burning, cracking, scaling, and discomfort accompanying these conditions

Dosage and Administration (34068-7)

Directions

  • clean the affected area and dry thoroughly
  • apply a thin layer of the product over the affected area twice daily (morning and night) or as directed by a physician
  • children under 12 years of age should be supervised in the use of this product
  • for athlete's foot: pay special attention to spaces between the toes: wear well-fitting, ventilated shoes: change shoes and socks at least once daily
  • for athletes foot and ringworm, use daily for 4 weeks: for jock itch, use daily for 2 weeks
  • this product is not effective on scalp or nails

Warnings and Precautions (34071-1)

Warnings

For external use only

  • When using this product avoid contact with the eyes

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 (for athlete's foot and ringworm) or 2 weeks (for jock itch)

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)

Other ingredients  Water, T36 C5 Melaleuca Oil, Stearic Acid, Cetyl alcohol, SD Alcohol 40B, Glyceryl Stearate and PEG 100 Stearate, Steareth 21, Propylene Glycol, Dimethicone, Acrylates/C10-30 Alkylacrylates Crosspolymer, Triethanolamine, Steareth 2, Benzyl Alcohol, Methylsothiazolinone, BHT.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Antifungal

Section 55106-9 (55106-9)

Active ingredients

Clotrimazole 1%


Advanced Ingredient Data


Raw Label Data

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