Miconazole Nitrate: Package Insert and Label Information

MICONAZOLE NITRATE- miconazole nitrate powder
Meijer Distribution Inc

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.

Active ingredient

Miconazole nitrate 2%

Purpose

Antifungal

Uses

for the cure of most athlete’s foot, jock itch and ringworm

Warnings

For external use only.

Do not use

on children 2 years of age unless directed by a doctor.

When using this product

avoid contact with the eyes

Stop 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.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • clean the affected area and dry thoroughly
  • apply a thin layer of 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 attention to spaces between the toes; wear well-fitting, ventilated shoes, & 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 conditions persists longer, consult a doctor
  • this product is not effective on the scalp or nails

Other information

store between 59º — 86ºF
lightly shake bottle to loosen settled powder

Inactive ingredients

allantoin, chloroxylenol, fragrance, imidazolidinyl urea, microcrystalline cellulose, tricalicum phosphate, zea mays (corn) starch

Questions?

call 1-866-964-0939

Principal Display Panel

meijer

miconazorbAF

Miconazole Nitrate | Antifungal

Antifungal Powder

TALC-FREE

Cures most athlete’s foot,

jock itch & ringworm

Relieves chafing, itching,

burning & scaling

Absorbs moisture

NET WT 2.5 OZ (71g)

AF Powder
(click image for full-size original)
MICONAZOLE NITRATE
anti-fungal powder miconazole nitrate talc free powder
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:41250-575
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MICONAZOLE NITRATE (MICONAZOLE) MICONAZOLE NITRATE 1.42 g in 71 g
Inactive Ingredients
Ingredient Name Strength
ALLANTOIN
CHLOROXYLENOL
IMIDUREA
MICROCRYSTALLINE CELLULOSE
TRICALCIUM PHOSPHATE
ZEA MAYS SUBSP. MAYS WHOLE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:41250-575-25 71 g in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333C 12/01/2017
Labeler — Meijer Distribution Inc (006959555)

Revised: 01/2021 Meijer Distribution Inc

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