sheffield clotrimazole cream 

sheffield clotrimazole cream 
SPL v8
SPL
SPL Set ID b8b8e6b2-1022-4592-91ba-3cf94c7cf318
Route
topical
Published
Effective Date 2025-02-19
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 Until 2024-11-30

Purpose

Antifungal Cream

Description

Drug Facts


Medication Information

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.

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 persist longer, consult a doctor.
  • This product is not effective on the scalp or nails.
Other Information
  • Store at controlled room temperature 68°-77°F (20°-25°C).
  • Close cap tightly after use.
Inactive Ingredients

Aloe Barbadensis Leaf Juice, Benzyl Alcohol, Cetearyl Alcohol, Cetyl Esters, Octyldodecanol, Polysorbate 60, Sorbitan Monostearate, Tocopheryl Acetate, Purified Water.

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1
  • Keep this and all drugs out of 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 not improvement within 4 weeks (for athlete's foot or ringworm) or within 2 weeks (for jock itch), discontinue use and consult a doctor.
Questions

1-800-222-1087

Active Ingredient

Clotrimazole 1 %

Principal Display Panel – 0.5 Oz Tube

Principal Display Panel – 0.5 OZ Tube

Sheffield NDC 11524-071-51

Athlete's

Foot Cream

Antifungal Cream

Clotrimazole 1%

Helps cure: • Athlete's Foot • Jock Itch • Ringworm

Made in the USA

NET WT. 0.5 OZ (14 g)

Principal Display Panel – 0.5oz Carton

Principal Display Panel – 0.5 OZ Carton

Sheffield NDC 11524-071-51

Athlete's

Foot Cream

Antifungal Cream

Clotrimazole 1%

Helps cure: • Athlete's Foot • Jock Itch • Ringworm

Made in the USA

NET WT. 0.5oz (14g)


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.

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 persist longer, consult a doctor.
  • This product is not effective on the scalp or nails.
Other Information (Other information)
  • Store at controlled room temperature 68°-77°F (20°-25°C).
  • Close cap tightly after use.
Inactive Ingredients (Inactive ingredients)

Aloe Barbadensis Leaf Juice, Benzyl Alcohol, Cetearyl Alcohol, Cetyl Esters, Octyldodecanol, Polysorbate 60, Sorbitan Monostearate, Tocopheryl Acetate, Purified Water.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)
  • Keep this and all drugs out of 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 not improvement within 4 weeks (for athlete's foot or ringworm) or within 2 weeks (for jock itch), discontinue use and consult a doctor.
Questions

1-800-222-1087

Active Ingredient (Active ingredient)

Clotrimazole 1 %

Principal Display Panel – 0.5 Oz Tube (Principal Display Panel – 0.5 OZ Tube)

Principal Display Panel – 0.5 OZ Tube

Sheffield NDC 11524-071-51

Athlete's

Foot Cream

Antifungal Cream

Clotrimazole 1%

Helps cure: • Athlete's Foot • Jock Itch • Ringworm

Made in the USA

NET WT. 0.5 OZ (14 g)

Principal Display Panel – 0.5oz Carton (Principal Display Panel – 0.5OZ Carton)

Principal Display Panel – 0.5 OZ Carton

Sheffield NDC 11524-071-51

Athlete's

Foot Cream

Antifungal Cream

Clotrimazole 1%

Helps cure: • Athlete's Foot • Jock Itch • Ringworm

Made in the USA

NET WT. 0.5oz (14g)


Advanced Ingredient Data


Raw Label Data

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