Label: SELAN ANTIFUNGAL cream
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Contains inactivated NDC Code(s)
NDC Code(s): 0159-2500-04 - Packager: Trividia Manufacturing Solutions, Inc
- 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 February 16, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
- Warnings
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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Directions
- Clean affected area and dry thoroughly
- Apply a thin layer over the affected area twice daily (morning and night) for 2 weeks (jock itch) or 4 weeks (athlete's foot & ringworm)
- Supervise children in the use of this product
For athlete's foot *pay special attention to the space between the toes *wear well fitting, ventilated shoes *change shoes and socks at least once daily
If condition persists longer, or if irritiation occurs, consult a doctor. This product is not effective on the scalp or nails.
- Other information
- Inactive ingredients:
- Image of 4oz tube
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INGREDIENTS AND APPEARANCE
SELAN ANTIFUNGAL
selan antifungal creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0159-2500 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 2 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) LANOLIN (UNII: 7EV65EAW6H) DIMETHICONE 1000 (UNII: MCU2324216) ZINC OXIDE (UNII: SOI2LOH54Z) POLAWAX POLYSORBATE (UNII: Q504PL8E0V) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0159-2500-04 117 g in 1 TUBE; Type 0: Not a Combination Product 11/05/2003 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 11/05/2003 Labeler - Trividia Manufacturing Solutions, Inc (018927392) Establishment Name Address ID/FEI Business Operations Trividia Manufacturing Solutions, Inc 018927392 manufacture(0159-2500) , label(0159-2500) , pack(0159-2500)