Miconazole Nitrate

Miconazole Nitrate
SPL v1
SPL
SPL Set ID da4702fa-d3e9-7c71-e053-2995a90af334
Route
TOPICAL
Published
Effective Date 2022-03-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (20 mg)
Inactive Ingredients
Apricot Kernel Oil Benzoic Acid Butylated Hydroxytoluene Glycol Stearate Mineral Oil Polyethylene Glycol 300 Water Peg-6 Stearate Peg-32 Stearate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 1991-10-01

Description

Drug Facts

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Drug Facts

Uses
  • effective in the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis)
  • for effective relief of itching, scaling, burning and discomfort that can accompany these conditions.
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Section 50567-7

When using this product avoid contact with eyes

Section 50570-1

Do not use on children less than 2 years of age unless directed by a doctor

Warnings

For external use only

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, and 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
  • not effective on the scalp or nails
Questions?

Call 1-866-923-4914

Active Ingredient

Miconazole nitrate USP 2%

Other Information
  • To open: unscrew cap, use pointed end on cap to puncture seal
  • store at 20° - 25°C (68° - 77°F)
  • see carton or tube crimp for lot number and expiration date
Inactive Ingredients

apricot kernel oil, benzoic acid, BHT, glycol stearate, mineral oil, PEG-6, PEG-6-32 stearate, purified water

Principal Display Panel

Stop Use and Ask A Doctor If
  • irritation occurs
  • condition persists
  • there is no improvement of athlete's foot or ringworm within 4 weeks or jock itch within 2 weeks.

Structured Label Content

Uses
  • effective in the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis)
  • for effective relief of itching, scaling, burning and discomfort that can accompany these conditions.
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Section 50567-7 (50567-7)

When using this product avoid contact with eyes

Section 50570-1 (50570-1)

Do not use on children less than 2 years of age unless directed by a doctor

Purpose

Antifungal

Warnings

For external use only

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, and 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
  • not effective on the scalp or nails
Questions?

Call 1-866-923-4914

Active Ingredient (Active ingredient)

Miconazole nitrate USP 2%

Other Information (Other information)
  • To open: unscrew cap, use pointed end on cap to puncture seal
  • store at 20° - 25°C (68° - 77°F)
  • see carton or tube crimp for lot number and expiration date
Inactive Ingredients (Inactive ingredients)

apricot kernel oil, benzoic acid, BHT, glycol stearate, mineral oil, PEG-6, PEG-6-32 stearate, purified water

Principal Display Panel (PRINCIPAL DISPLAY PANEL -)

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • irritation occurs
  • condition persists
  • there is no improvement of athlete's foot or ringworm within 4 weeks or jock itch within 2 weeks.

Advanced Ingredient Data


Raw Label Data

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