Dermachange Foot And Jock Powder, 2% Miconazole Nitrate

Dermachange Foot And Jock Powder, 2% Miconazole Nitrate
SPL v1
SPL
SPL Set ID 12eef049-76c9-1450-e063-6394a90a00ea
Route
TOPICAL
Published
Effective Date 2024-03-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (2 g)
Inactive Ingredients
Sodium Benzoate Starch, Corn Potassium Sorbate Starch, Rice

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-10-25

Description

Miconazole Nitrate 2%


Medication Information

Warnings and Precautions

For external use only. Do not use on children under 2 years of age unless directed by a doctor or for diaper rash. When using this product avoid contact with the eyes. Stop use and ask a doctor if irritation occurs or if there is no improvement within 2 weeks.

Indications and Usage

For the cure of athlete's foot and jock itch. Relieves itching and chafing associated with jock itch.

Dosage and Administration

Jock Powder

Cleanse the affected area and dry thoroughly. Apply a thin layer of the product over the affected area twice daily or as directed by a doctor.

Supervise children in the use of this product.

Use daily for 2 weeks.

If the condition persists, consult a doctor.

This product is not effective on the scalp or nails.

Foot Powder

Cleanse the affected area and dry thoroughly. Apply a thin layer of the product over the affected area twice daily or as directed by a doctor.

For athlete's foot: pay special attention to space between toes; wear well-fitting ventilated shoes and change socks at least once daily.

Supervise children in the use of this product.

Use daily for 4 weeks.

If the condition persists, consult a doctor.

This product is not effective on the scalp or nails.

Description

Miconazole Nitrate 2%

Section 50565-1

If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

Corn Starch, Fragrance, Potassium Sorbate, Rice Starch, Sodium Benzoate.

Section 51945-4

Dermachange Jock Powder, NDC 83520-961-21

Dermachange Foot Powder, NDC 83520-961-02

Section 55105-1

Antifungal

Section 55106-9

Miconazole Nitrate 2%


Structured Label Content

Indications and Usage (34067-9)

For the cure of athlete's foot and jock itch. Relieves itching and chafing associated with jock itch.

Dosage and Administration (34068-7)

Jock Powder

Cleanse the affected area and dry thoroughly. Apply a thin layer of the product over the affected area twice daily or as directed by a doctor.

Supervise children in the use of this product.

Use daily for 2 weeks.

If the condition persists, consult a doctor.

This product is not effective on the scalp or nails.

Foot Powder

Cleanse the affected area and dry thoroughly. Apply a thin layer of the product over the affected area twice daily or as directed by a doctor.

For athlete's foot: pay special attention to space between toes; wear well-fitting ventilated shoes and change socks at least once daily.

Supervise children in the use of this product.

Use daily for 4 weeks.

If the condition persists, consult a doctor.

This product is not effective on the scalp or nails.

Warnings and Precautions (34071-1)

For external use only. Do not use on children under 2 years of age unless directed by a doctor or for diaper rash. When using this product avoid contact with the eyes. Stop use and ask a doctor if irritation occurs or if there is no improvement within 2 weeks.

Section 50565-1 (50565-1)

If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Corn Starch, Fragrance, Potassium Sorbate, Rice Starch, Sodium Benzoate.

Section 51945-4 (51945-4)

Dermachange Jock Powder, NDC 83520-961-21

Dermachange Foot Powder, NDC 83520-961-02

Section 55105-1 (55105-1)

Antifungal

Section 55106-9 (55106-9)

Miconazole Nitrate 2%


Advanced Ingredient Data


Raw Label Data

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