Dermatin Antifungal Cream Content Of Label

Dermatin Antifungal Cream Content Of Label
SPL v1
SPL
SPL Set ID 5ce14151-31cc-4e3f-ac32-008fe8bc2f3e
Route
TOPICAL
Published
Effective Date 2011-02-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2011-12-19

Description

Active ingredient 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 athlete's 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 ingredient 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  acrylates/C10-30 alkyl acrylates crosspolymer, benzyl alcohol, cetyl alcohol, deionized water, dimethicone, glyceryl stearate and PEG-100 stearate, propylene glycol, SD alcohol 40B, steareth-2, steareth-21, stearic acid, T36-C5® Melaleuca alternifolia (Tea Tree) leaf oil, triethanolamine.

Section 51945-4
Section 55105-1

Purpose

Antifungal

Section 55106-9

Active ingredient

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 athlete's 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  acrylates/C10-30 alkyl acrylates crosspolymer, benzyl alcohol, cetyl alcohol, deionized water, dimethicone, glyceryl stearate and PEG-100 stearate, propylene glycol, SD alcohol 40B, steareth-2, steareth-21, stearic acid, T36-C5® Melaleuca alternifolia (Tea Tree) leaf oil, triethanolamine.

Section 51945-4 (51945-4)
Section 55105-1 (55105-1)

Purpose

Antifungal

Section 55106-9 (55106-9)

Active ingredient

Clotrimazole 1%


Advanced Ingredient Data


Raw Label Data

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