Miconazole Nitrate 2% Cream Antifungal

Miconazole Nitrate 2% Cream Antifungal
SPL v2
SPL
SPL Set ID e6734616-c16b-430c-e053-2a95a90a18f8
Route
TOPICAL
Published
Effective Date 2022-08-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (2 g)
Inactive Ingredients
Cetostearyl Alcohol Dimethicone Edetate Disodium Peg-100 Stearate Water Stearic Acid Xanthan Gum Glyceryl Monostearate Polyoxyl 20 Cetostearyl Ether Chlorocresol Propylene Glycol Sodium Cetostearyl Sulfate Imidurea Peg-40 Castor Oil Petrolatum Caprylic/capric/lauric Triglyceride

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-03-22

Description

Miconazole Nitrate 2% w/w

Purpose

Anti-Fungal


Medication Information

Purpose

Anti-Fungal

Description

Miconazole Nitrate 2% w/w

Uses
  • For the treatment and prevention of most athlete's foot (tinea pedis), jock itch (tinea crurus), and ringworm (tinea capitis)
  • relieves itching, scaling, cracking, burning and discomfort associated with these conditions.
Section 50570-1

on children under 2 years of age unless directed by Doctor

Section 51727-6

Caprylic/capric triglyceride, Cetereath-20, Cetearyl Alcohol, Chlorocresol, Dimethicone, Disodium EDTA, Glyceryl Stearate, Imidazolidinyl Urea, PEG-100 Stearate, PEG-40 Castor Oil, Petrolatum, Propylene Glycol, Sodium Cetearyl Sulfate, Stearic Acid, Water, Xanthum Gum

Section 51945-4

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 healthcare professional • Supervise children in the use of this product.

For athlete's foot: • Use daily for 4 weeks. If condition persists, consult a healthcare professional. • Pay special attention to the spaces between the toes • Wear well fitting, ventilated shoes • Change socks atleast once daily.

For ringworm: Use daily for 4 weeks. If condition persists, consult a healthcare professional.

For jock itch:Use daily for 2 weeks. If condition persists longer, consult a healthcare professional.

This product is not effective on the scalp or nails.

Drug Facts

Active Ingredient

Miconazole Nitrate 2% w/w

Other Information

• Store at 15° - 30° c (59° - 86° f)

When Using This Product

Avoid contact with eyes

Stop Use and Ask A Doctor If

irritation occurs

there is no improvement within 4 weeks (for athlete's foot or ringworm) or 2 weeks (for jock itch)

Keep Out of Reach of Children

In case of accidental ingestion contact a physician or Poison Control Center right away and discomfort which accompany these conditions


Structured Label Content

Uses
  • For the treatment and prevention of most athlete's foot (tinea pedis), jock itch (tinea crurus), and ringworm (tinea capitis)
  • relieves itching, scaling, cracking, burning and discomfort associated with these conditions.
Section 50570-1 (50570-1)

on children under 2 years of age unless directed by Doctor

Section 51727-6 (51727-6)

Caprylic/capric triglyceride, Cetereath-20, Cetearyl Alcohol, Chlorocresol, Dimethicone, Disodium EDTA, Glyceryl Stearate, Imidazolidinyl Urea, PEG-100 Stearate, PEG-40 Castor Oil, Petrolatum, Propylene Glycol, Sodium Cetearyl Sulfate, Stearic Acid, Water, Xanthum Gum

Section 51945-4 (51945-4)

Purpose

Anti-Fungal

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 healthcare professional • Supervise children in the use of this product.

For athlete's foot: • Use daily for 4 weeks. If condition persists, consult a healthcare professional. • Pay special attention to the spaces between the toes • Wear well fitting, ventilated shoes • Change socks atleast once daily.

For ringworm: Use daily for 4 weeks. If condition persists, consult a healthcare professional.

For jock itch:Use daily for 2 weeks. If condition persists longer, consult a healthcare professional.

This product is not effective on the scalp or nails.

Drug Facts

Active Ingredient (Active ingredient)

Miconazole Nitrate 2% w/w

Other Information

• Store at 15° - 30° c (59° - 86° f)

When Using This Product (When using this product)

Avoid contact with eyes

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

irritation occurs

there is no improvement within 4 weeks (for athlete's foot or ringworm) or 2 weeks (for jock itch)

Keep Out of Reach of Children (Keep out of reach of children)

In case of accidental ingestion contact a physician or Poison Control Center right away and discomfort which accompany these conditions


Advanced Ingredient Data


Raw Label Data

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