Miconazole Nitrate: Package Insert and Label Information

MICONAZOLE NITRATE- miconazole nitrate aerosol, spray
American Sales Company

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

  • cures most jock itch (tinea cruris)
  • relieves symptoms of jock itch including itching, burning and chafing associated with jock itch

Warnings

For external use only.

Flammable:

Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120ºF.

When using this product

  • do not get into eyes or mouth
  • use only as directed. Intentional misuse by deliberately concentrating and inhaling contents cans be harmful or fatal.

Stop use and ask a doctor if

  • irritation occurs
  • no improvement within 2 weeks for jock itch

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. Do not use on children under 2 years of age. Do not use for diaper rash. Do not use on children under 2 years of age unless directed by a doctor.

Directions

  • wash affected area and dry thoroughly
  • shake can well and spray a thin layer over affected area twice daily (morning and night)
  • supervise children in the use of this product
  • use daily for 2 weeks. If conditions persist, consult a doctor
  • this product is not effective on scalp or nails
  • in case of clogging, clear nozzle under running water

Inactive ingredient

Disteardimonium Hectorite, Isobutane, Kaolin, SD Alcohol 40-B, Zea Mays (Corn) Starch

Questions?

Call 1-866-964-0939

PRINCIPAL DISPLAY PANEL

CareOne

ANTIFUNGAL

JOCK ITCH

POWDER SPRAY

MICONAZOLE NITRATE 2%

CURES MOST JOCK ITCH

RELIEVES ITCHING, CHAFING, AND BURNING

TALC- FREE

NET WT 4.6 OZ (130 g)

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MICONAZOLE NITRATE
jock itch spray talc free aerosol, spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:41520-566
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MICONAZOLE NITRATE (MICONAZOLE) MICONAZOLE NITRATE 1.3 g in 130 g
Inactive Ingredients
Ingredient Name Strength
DISTEARDIMONIUM HECTORITE
ISOBUTANE
KAOLIN
ALCOHOL
ZEA MAYS SUBSP. MAYS WHOLE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:41520-566-46 130 g in 1 CAN None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333C 10/20/2017
Labeler — American Sales Company (809183973)

Revised: 12/2019 American Sales Company

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