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 November 25, 2020
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- Active Ingredient
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 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 reaction develops
- there is no improvement within 4 weeks, when used for athlete's foot or ringworm.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Indications and Usage
- 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 toes: wear well fitting, ventilated shoes, and change shoes and socks at least once daily.
- Dosage and Administration
- Keep Out Of Reach Of Children
- INACTIVE INGREDIENTS
- STORAGE AND HANDLING
- 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 CETETH-20 (UNII: I835H2IHHX) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) LIGHT MINERAL OIL (UNII: N6K5787QVP) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) PETROLATUM (UNII: 4T6H12BN9U) 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 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:68001-475-46 1 in 1 CARTON 11/25/2020 2 15 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC:68001-475-45 1 in 1 CARTON 11/25/2030 3 14 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)