Label: CLOTRIMAZOLE CREAM 1% cream
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Contains inactivated NDC Code(s)
NDC Code(s): 70512-100-15, 70512-100-30 - Packager: SOLA Pharmaceuticals
- 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.
Drug Label Information
Updated July 5, 2022
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Usage
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Warnings
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 no improvement within 4 weeks (for athlete's foot or ringworm) or 2 weeks (for jock itch), discontinue use and consult a doctor.
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.
- KEEP OUT OF REACH OF CHILDREN
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Directions
- Clean the affected area and dry thoroughly. Apply a layer of cream over the affected area twice daily morning and night or as directed by doctor.
- Supervise children in the use of this product.
- For athlete's foot pay special attention to the spaces between 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 persist longer consult a doctor.
- This product is not effective on scalp or nails.
- Inactive Ingredients
- Other Information
- Package Display Panel
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INGREDIENTS AND APPEARANCE
CLOTRIMAZOLE CREAM 1%
clotrimazole cream 1% creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70512-100 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 MINERAL OIL (UNII: T5L8T28FGP) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) CETETH-20 (UNII: I835H2IHHX) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) PETROLATUM (UNII: 4T6H12BN9U) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) METHYLPARABEN (UNII: A2I8C7HI9T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70512-100-30 1 in 1 CARTON 04/14/2020 1 30 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:70512-100-15 1 in 1 CARTON 10/21/2021 2 14.2 g in 1 TUBE; 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 04/14/2020 Labeler - SOLA Pharmaceuticals (080121345)
