SPL v4
SPL
SPL Set ID 562dfc9f-1897-330a-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2017-08-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (10 mg)
Inactive Ingredients
Water Cetostearyl Alcohol Polysorbate 60 Benzyl Alcohol Sorbitan Monostearate .alpha.-tocopherol Acetate Aloe Vera Leaf Octyldodecanol Cetyl Palmitate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2004-10-04

Description

Drug Facts

Purpose

Antifungal Cream


Medication Information

Purpose

Antifungal Cream

Description

Drug Facts

Uses

Cures athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis). Relieves the itching, irritation, redness, scaling and discomfort which can accompany these conditions.

Section 42229-5

Drug Facts

Section 50565-1
  • Keep this and all drugs out of the reach of children.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Section 50570-1
  • Do not use on children under 2 years of age unless directed by a doctor.
  • For external use only.
  • Avoid contact with eyes.
  • If irritation occurs or if there is no improvement within 4 weeks (for athlete's foot or ringworm) or within 2 weeks (for jock itch), discontinue use and consult a doctor.
Directions
  • Clean the affected area and dry thoroughly.
  • Apply a thin layer of this product 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.
  • For athlete's foot and ringworm, use daily for 4 weeks. For jock itch, use daily for 2 weeks.
  • If conditions persists longer, consult a doctor.
  • This product is not effective on the scalp or nails.
Questions?

Adverse Drug Event call (800)616-2471

Dist. By MAJOR PHARMACEUTICALS

31778 Enterprise Drive, Livonia, Ml 48150 USA

Re-Oder No. 100431

Active Ingredient

Clotrimazole USP 1% w/w

Other Information
  • Store at controlled room temperature 15°-30°C (59°-86°F).
  • Close cap tightly after use.
Inactive Ingredients

aloe vera, benzyl alcohol, cetearyl alcohol, 2-octyldodecanol, polysorbate 60, sorbitan monostearate, spermwax, vitamin E, water

Principal Display Panel – 1 Oz. Tube


Structured Label Content

Uses

Cures athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis). Relieves the itching, irritation, redness, scaling and discomfort which can accompany these conditions.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)
  • Keep this and all drugs out of the reach of children.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Section 50570-1 (50570-1)
  • Do not use on children under 2 years of age unless directed by a doctor.
  • For external use only.
  • Avoid contact with eyes.
  • If irritation occurs or if there is no improvement within 4 weeks (for athlete's foot or ringworm) or within 2 weeks (for jock itch), discontinue use and consult a doctor.
Purpose

Antifungal Cream

Directions
  • Clean the affected area and dry thoroughly.
  • Apply a thin layer of this product 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.
  • For athlete's foot and ringworm, use daily for 4 weeks. For jock itch, use daily for 2 weeks.
  • If conditions persists longer, consult a doctor.
  • This product is not effective on the scalp or nails.
Questions?

Adverse Drug Event call (800)616-2471

Dist. By MAJOR PHARMACEUTICALS

31778 Enterprise Drive, Livonia, Ml 48150 USA

Re-Oder No. 100431

Active Ingredient (Active ingredient)

Clotrimazole USP 1% w/w

Other Information (Other information)
  • Store at controlled room temperature 15°-30°C (59°-86°F).
  • Close cap tightly after use.
Inactive Ingredients (Inactive ingredients)

aloe vera, benzyl alcohol, cetearyl alcohol, 2-octyldodecanol, polysorbate 60, sorbitan monostearate, spermwax, vitamin E, water

Principal Display Panel – 1 Oz. Tube (Principal Display Panel – 1 oz. Tube)


Advanced Ingredient Data


Raw Label Data

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