Label: CLOTRIMAZOLE solution
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- NDC Code(s): 68784-301-01, 68784-301-10
- Packager: ACINO PRODUCTS LIMITED LIABILITY COMPANY
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated May 19, 2021
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- ACTIVE INGREDIENT
- PURPOSE
-
USES
Cures most
• Athlete's foot (tinea pedis)
• Jock Itch (tinea cruris)
• Ringworm (tinea corporis)Effectively relieves
• Itching
• Cracking
• Burning
• Discomfort which can accompany these conditions
• This product is not effective on the scalp or nails. For best results, follow directions and continue treatment for length of time indicated. For athlete's foot and ringworm: use daily for 4 weeks. For jock itch: use daily for 2 weeks.
• clean the affected area and dry thoroughly
• apply a thin layer of the 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 spaces between the toes; wear well-fitting, ventilated shoes; change shoes and socks at least once daily. - WARNINGS
- KEEP OUT OF REACH OF CHILDREN
-
DIRECTIONS
- This product is not effective on the scalp or nails. For best results, follow directions and continue treatment for length of time indicated. For athlete's foot and ringworm: use daily for 4 weeks. For jock itch: use daily for 2 weeks.
- clean the affected area and dry thoroughly
- apply a thin layer of the 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 spaces between the toes; wear well-fitting, ventilated shoes; change shoes and socks at least once daily.
- OTHER INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
CLOTRIMAZOLE
clotrimazole solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68784-301 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE 1 g in 100 mL Inactive Ingredients Ingredient Name Strength POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68784-301-10 1 in 1 BOX 07/29/2019 1 NDC:68784-301-01 10 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 07/29/2019 Labeler - ACINO PRODUCTS LIMITED LIABILITY COMPANY (019385518) Establishment Name Address ID/FEI Business Operations ACINO PRODUCTS LIMITED LIABILITY COMPANY 019385518 manufacture(68784-301)
