miconazole nitrate

miconazole nitrate
SPL v3
SPL
SPL Set ID 966a1000-3b08-4f2c-a9f8-568f2524b717
Route
topical
Published
Effective Date 2023-07-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
miconazole (20 mg)
Inactive Ingredients
benzoic acid butylated hydroxytoluene mineral oil peg-7 linoleoyl glycerides glycol stearate water

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2023-07-14

Purpose

Antifungal

Description

Drug Facts


Medication Information

Warnings

For external use only

Uses
  • proven clinically effective in the treatment of most athlete's foot, jock itch and ringworm
  • for effective relief of itching, scaling, burning and discomfort that can accompany these conditions
Purpose

Antifungal

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 the 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
Other Information
  • TAMPER EVIDENT: DO NOT USE IF THE SEAL ON THE TUBE IS PUNCTURED OR NOT VISIBLE.
  • to open: unscrew cap, use the pointed end on cap to puncture seal
  • store at 20° to 25°C (68° to 77°F)
  • see carton flap or tube crimp for lot number and expiration date
Inactive Ingredients

benzoic acid (0.20%) as a preservative, butylated hydroxytoluene, mineral oil, oleoyl polyoxylglyceride, PEG-6-32 stearate/glycol stearate, and purified water

Description

Drug Facts

Questions?

call 833-358-6431

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 productavoid contact with the eyes

Section 50570-1

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

Active Ingredient

Miconazole nitrate USP 2%

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
Principal Display Panel 30 G Tube Carton

Foster & Thrive™

Antifungal Cream

Miconazole Nitrate Cream USP, 2%

ANTIFUNGAL

NET WT 1 OZ (30 g)


Structured Label Content

Warnings

For external use only

Uses
  • proven clinically effective in the treatment of most athlete's foot, jock itch and ringworm
  • for effective relief of itching, scaling, burning and discomfort that can accompany these conditions
Purpose

Antifungal

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 the 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
Other Information (Other information)
  • TAMPER EVIDENT: DO NOT USE IF THE SEAL ON THE TUBE IS PUNCTURED OR NOT VISIBLE.
  • to open: unscrew cap, use the pointed end on cap to puncture seal
  • store at 20° to 25°C (68° to 77°F)
  • see carton flap or tube crimp for lot number and expiration date
Inactive Ingredients (Inactive ingredients)

benzoic acid (0.20%) as a preservative, butylated hydroxytoluene, mineral oil, oleoyl polyoxylglyceride, PEG-6-32 stearate/glycol stearate, and purified water

Questions?

call 833-358-6431

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 productavoid contact with the eyes

Section 50570-1 (50570-1)

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

Active Ingredient (Active ingredient)

Miconazole nitrate USP 2%

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
Principal Display Panel 30 G Tube Carton (PRINCIPAL DISPLAY PANEL - 30 g Tube Carton)

Foster & Thrive™

Antifungal Cream

Miconazole Nitrate Cream USP, 2%

ANTIFUNGAL

NET WT 1 OZ (30 g)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)