SPL v1
SPL
SPL Set ID 4200b518-eaa9-47f7-babc-793fd54cbde1
Route
TOPICAL
Published
Effective Date 2025-05-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (1 g)
Inactive Ingredients
Alcohol Butylated Hydroxytoluene Cetostearyl Alcohol Dimethyl Sulfoxide Edetate Disodium Ethylparaben Glycerin Mineral Oil Glyceryl Mono- And Dipalmitostearate Petrolatum Glycereth-31 Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-19

Description

Clotrimazole USP 1% w/w


Medication Information

Warnings and Precautions
  • For external use only
  • Do not use onchildren under 2 years of age unless directed by a doctor. 
  • When using this productavoid contact with eyes. 
  • Stop use and ask a doctor if 
  • Irritation occurs 
  • There is no improvement within 4 weeks (for athlete's foot or ringworm) or within 2 weeks (for jock itch). 
  • 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 right away.
Indications and Usage
  • Cures athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis).
  • Relieves the itching, irritation, redness, scaling and discomfort which can accompany these conditions.
Dosage and Administration
  • Wash the 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. 
  • For athlete's foot and ringworm, use daily for 4 weeks. For jock itch, use daily for 2 weeks. 
  • If condition persists longer, consult a doctor. 
  • This product is not effective on the scalp or nails.
Description

Clotrimazole USP 1% w/w

Section 42229-5
  • Store at controlled room temperature 15° - 30°C (59° - 86°F)
  • Close cap tightly after use.
Section 51727-6

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Alcohol, Aloe Barbadensis Leaf Juice, Cetearyl Alcohol, Cetyl Esters, Curcuma Longa (Turmeric)

Root Extract, Ethylhexyl Palmitate, Ethylhexylglycerin, Eugenia Caryophyllus (Clove) Flower Extract, Glycerin, Hamamelis Virginiana (Witch Hazel) Water, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Phenoxyethanol, Polysorbate 20, Sorbitan Stearate,Tocopheryl Acetate, Triethanolamine, Water (Aqua)

Section 51945-4

Section 55105-1

Antifungal

Section 55106-9

Clotrimazole USP 1% w/w


Structured Label Content

Indications and Usage (34067-9)
  • Cures athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis).
  • Relieves the itching, irritation, redness, scaling and discomfort which can accompany these conditions.
Dosage and Administration (34068-7)
  • Wash the 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. 
  • For athlete's foot and ringworm, use daily for 4 weeks. For jock itch, use daily for 2 weeks. 
  • If condition persists longer, consult a doctor. 
  • This product is not effective on the scalp or nails.
Warnings and Precautions (34071-1)
  • For external use only
  • Do not use onchildren under 2 years of age unless directed by a doctor. 
  • When using this productavoid contact with eyes. 
  • Stop use and ask a doctor if 
  • Irritation occurs 
  • There is no improvement within 4 weeks (for athlete's foot or ringworm) or within 2 weeks (for jock itch). 
  • 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 right away.
Section 42229-5 (42229-5)
  • Store at controlled room temperature 15° - 30°C (59° - 86°F)
  • Close cap tightly after use.
Section 51727-6 (51727-6)

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Alcohol, Aloe Barbadensis Leaf Juice, Cetearyl Alcohol, Cetyl Esters, Curcuma Longa (Turmeric)

Root Extract, Ethylhexyl Palmitate, Ethylhexylglycerin, Eugenia Caryophyllus (Clove) Flower Extract, Glycerin, Hamamelis Virginiana (Witch Hazel) Water, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Phenoxyethanol, Polysorbate 20, Sorbitan Stearate,Tocopheryl Acetate, Triethanolamine, Water (Aqua)

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antifungal

Section 55106-9 (55106-9)

Clotrimazole USP 1% w/w


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)