Miconazole Nitrate

Miconazole Nitrate
SPL v2
SPL
SPL Set ID 25520dba-0159-2a3f-e063-6294a90a4c33
Route
TOPICAL
Published
Effective Date 2024-10-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (20 mg)
Inactive Ingredients
Cetostearyl Alcohol Chlorocresol Ceteareth-12 2-phenylpropanal Propylene Glycol Acetal Sodium Phosphate Dibasic Dihydrate Sodium Phosphate, Monobasic, Anhydrous Light Mineral Oil Water White Petrolatum Edetate Disodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-10-25

Description

For the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis) Relieves itching, scaling, burning, discomfort and chafing associated with jock itch or itching, burning feet


Medication Information

Description

For the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis) Relieves itching, scaling, burning, discomfort and chafing associated with jock itch or itching, burning feet

Uses

For the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis) Relieves itching, scaling, burning, discomfort

and chafing associated with jock itch or itching, burning feet

Section 51945-4

Purposde

Miconazole Nitrate 2% ........................................................................................................................................................................................................................................................................... Antifungal

Do Not Use

Do not use On children under 2 years of age unless directed by a

doctor For diaper rash.

When using this product Avoid contact with the eyes

Active Ingrediant

Miconazole Nitrate 2%

Other Information

Do not use if seal on the tube is damaged or

is not visible. To open, unscrew cap, pull tab to remove foil seal See

crimp of tube or carton for Lot Number and Expiry Date Preserve in

well-closed containers, and store controlled room temperature

Directions and Uses

Uses

For the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis) Relieves itching, scaling, burning, discomfort

and chafing associated with jock itch or itching, burning feet

Clean the affected area and dry thoroughly Apply a thin layer of the cream 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 If condition persists longer, consult a doctor This product is not effective on the scalp or nails

Inactive Ingredients

Inactive Ingredients Cetostearyl Alcohol, Chlorocresol, Edetate

Disodium, Light Mineral Oil, Macrogol Cetostearyl Ether, Propylene

Glycol, Purified Water, Sodium Phosphate Dibasic Dihydrate, Sodium

Phosphate Monobasic Dihydrate, White Petrolatum

Stop Use and Ask A Doctor If

Stop use and ask a doctor if Irritation occurs There is no

improvement within 2 weeks when used for the treatment of jock

itch There is no improvement within 4 weeks when used for athlete's

foot and ringworm

Keep Out of Reach of Children

Keep out of reach of children. If swallowed, get medical help or

contact a Poison Control Center right away.

Warnings for External Use Only

Miconazole Nitrate 2%

For External Use Only

Do not use On children under 2 years of age unless directed by a doctor For diaper rash.

When using this product Avoid contact with the eyes

Stop use and ask a doctor if Irritation occurs There is no improvement within 2 weeks when used for the treatment of jock itch There is no

improvement within 4 weeks when used for athlete's foot and ringworm

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Warnings for External Use Only

Do not use On children under 2 years of age unless directed by a doctor For diaper rash.

When using this product Avoid contact with the eyes

Stop use and ask a doctor if Irritation occurs There is no improvement within 2 weeks when used for the treatment of jock itch There is no

improvement within 4 weeks when used for athlete's foot and ringworm

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses

For the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis) Relieves itching, scaling, burning, discomfort

and chafing associated with jock itch or itching, burning feet

Section 51945-4 (51945-4)

Purposde (PURPOSDE)

Miconazole Nitrate 2% ........................................................................................................................................................................................................................................................................... Antifungal

Do Not Use (Do not use)

Do not use On children under 2 years of age unless directed by a

doctor For diaper rash.

When using this product Avoid contact with the eyes

Active Ingrediant

Miconazole Nitrate 2%

Other Information

Do not use if seal on the tube is damaged or

is not visible. To open, unscrew cap, pull tab to remove foil seal See

crimp of tube or carton for Lot Number and Expiry Date Preserve in

well-closed containers, and store controlled room temperature

Directions and Uses (DIRECTIONS AND USES)

Uses

For the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis) Relieves itching, scaling, burning, discomfort

and chafing associated with jock itch or itching, burning feet

Clean the affected area and dry thoroughly Apply a thin layer of the cream 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 If condition persists longer, consult a doctor This product is not effective on the scalp or nails

Inactive Ingredients

Inactive Ingredients Cetostearyl Alcohol, Chlorocresol, Edetate

Disodium, Light Mineral Oil, Macrogol Cetostearyl Ether, Propylene

Glycol, Purified Water, Sodium Phosphate Dibasic Dihydrate, Sodium

Phosphate Monobasic Dihydrate, White Petrolatum

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

Stop use and ask a doctor if Irritation occurs There is no

improvement within 2 weeks when used for the treatment of jock

itch There is no improvement within 4 weeks when used for athlete's

foot and ringworm

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

Keep out of reach of children. If swallowed, get medical help or

contact a Poison Control Center right away.

Warnings for External Use Only (WARNINGS FOR EXTERNAL USE ONLY)

Miconazole Nitrate 2%

For External Use Only

Do not use On children under 2 years of age unless directed by a doctor For diaper rash.

When using this product Avoid contact with the eyes

Stop use and ask a doctor if Irritation occurs There is no improvement within 2 weeks when used for the treatment of jock itch There is no

improvement within 4 weeks when used for athlete's foot and ringworm

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Warnings for External Use Only (Warnings For External Use Only)

Do not use On children under 2 years of age unless directed by a doctor For diaper rash.

When using this product Avoid contact with the eyes

Stop use and ask a doctor if Irritation occurs There is no improvement within 2 weeks when used for the treatment of jock itch There is no

improvement within 4 weeks when used for athlete's foot and ringworm

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


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