Label: ANTIFUNGAL CREAM- antifungal cream
- NDC Code(s): 68001-475-45, 68001-475-46, 68001-475-47
- Packager: BluePoint 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 October 13, 2021
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- SPL UNCLASSIFIED SECTION
- Active ingredient
For external use only
Do not use:
- on children under 2 years of age unless directed by a doctor.
When using this product
- Avoid contact with 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.
- Keep Out Of Reach Of Children
- 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.
- DOSAGE & ADMINISTRATION
- Other Information
- INACTIVE INGREDIENTS
- PRINCIPAL DISPLAY PANEL
- Principal Display Panel
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68001-475 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 g Inactive Ingredients Ingredient Name Strength PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) WHITE PETROLATUM (UNII: B6E5W8RQJ4) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) MINERAL OIL (UNII: T5L8T28FGP) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68001-475-47 1 in 1 CARTON 11/25/2020 1 28.4 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:68001-475-46 1 in 1 CARTON 11/25/2020 06/14/2021 2 15 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC:68001-475-45 1 in 1 CARTON 11/25/2020 3 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 11/25/2020 Labeler - BluePoint Laboratories (985523874) Establishment Name Address ID/FEI Business Operations Gopaldas Visram & Co., Ltd 858030888 manufacture(68001-475)