Label: CLOTRIMAZOLE solution
- NDC Code(s): 0536-1181-70
- Packager: RUGBY LABORATORIES
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated August 19, 2021
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- Active ingredient
- Ask a doctor before use
- When using this product
- Stop use and ask a doctor if
- Keep out of the reach of children.
- 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 or comments?
- Clotrimazole 1% Topical Solution
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-1181 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE 1 g in 1 mL Inactive Ingredients Ingredient Name Strength POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0536-1181-70 10 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/20/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 08/20/2018 Labeler - RUGBY LABORATORIES (079246066)