Label: CLOTRIMAZOLE cream
- NDC Code(s): 84387-004-01
- Packager: ALLIED TRADE LINK LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated November 8, 2024
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DOSAGE AND ADMISITRATION
Clotrimazole 1% ..
Clean the affected area and dry thoroughly. Apply a thin layer of cream 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 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
For External Use Only
Do not use On children under 2 years of age unless directed by a doctor For diaper rash.
When using this product Avoid contact with the eyes
Stop use and ask a doctor if Irritation occurs There is no improvement within 2 weeks when used for the treatment of jock itch There is no
improvement within 4 weeks when used for athlete’s foot or ringworm - INACTIVE INGREDIENT
- INDICATIONS & USAGE
- KEEP OUT OF REACH OF CHILDREN
- PURPOSE
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WARNINGS
For External Use Only
Do not use On children under 2 years of age unless directed by a doctor For diaper rash.
When using this product Avoid contact with the eyes
Stop use and ask a doctor if Irritation occurs There is no improvement within 2 weeks when used for the treatment of jock itch There is no
improvement within 4 weeks when used for athlete’s foot or ringworm - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CLOTRIMAZOLE
clotrimazole creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:84387-004 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE 10 mg in 1 g Inactive Ingredients Ingredient Name Strength METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WHITE PETROLATUM (UNII: B6E5W8RQJ4) PROPYLPARABEN (UNII: Z8IX2SC1OH) MINERAL OIL (UNII: T5L8T28FGP) WATER (UNII: 059QF0KO0R) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:84387-004-01 28.4 g in 1 TUBE; Type 0: Not a Combination Product 11/08/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M005 11/08/2024 Labeler - ALLIED TRADE LINK LLC (029033682) Registrant - ALLIED TRADE LINK LLC (029033682) Establishment Name Address ID/FEI Business Operations GOLPALDAS VISRAM AND COMPANY LIMITED 858030888 manufacture(84387-004)