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)

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