Label: EVERCARE ANTIFUNGAL TREATMENT SUPER ABSORBENT POWDER- miconazole nitrate powder
- NDC Code(s): 83099-000-00
- Packager: PANEFFORT, LLC
- 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 November 9, 2022
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient
For external use only.
Flammable, Do not use while smoking or near heat or flame.
When using this product
- avoid contact with eyes. If product gets into eyes, rinse thoroughly with water.
Stop use and ask a doctor
if irritation occurs or there is no improvement within 4 weeks for athlete's foot and ringworm, or 2 weeks for jock itch
clean the affected area& dry thoroughly apply a thin layerof 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 attenting to spaces between the toes;wear wellfitting, ventilated shoes, & change shoes& socks at least once daily for athlete's foot&ringworm, use daily for 4 weeks, for jock itch, use daily for 2 weeks if condition persists longer, consult a doctor this product is not effective on the scalp or nails
- Other information
- Inactive ingredients
- Package Labeling:
INGREDIENTS AND APPEARANCE
EVERCARE ANTIFUNGAL TREATMENT SUPER ABSORBENT POWDER
miconazole nitrate powder
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83099-000 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 20 mg in 1 g Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) SODIUM BICARBONATE (UNII: 8MDF5V39QO) KAOLIN (UNII: 24H4NWX5CO) ZINC OXIDE (UNII: SOI2LOH54Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83099-000-00 85 g in 1 POUCH; Type 0: Not a Combination Product 11/28/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 11/28/2022 Labeler - PANEFFORT, LLC (018250858)