Miconazole Nitrate 2% Cream Antifungal

Miconazole Nitrate 2% Cream Antifungal
SPL v5
SPL
SPL Set ID 76ee5b72-9ca3-5030-e053-2a91aa0a475f
Route
TOPICAL
Published
Effective Date 2018-09-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (2 g)
Inactive Ingredients
Petrolatum Carboxypolymethylene Cetostearyl Alcohol Dimethyl Sulfoxide Edetate Disodium Ethylparaben Glycerin Glyceryl Distearate Mineral Oil Polyoxyl 20 Cetostearyl Ether Water Stearic Acid Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2018-09-28

Description

Miconazole Nitrate 2%

Purpose

Anti-Fungal


Medication Information

Purpose

Anti-Fungal

Description

Miconazole Nitrate 2%

Uses
  • proven clinically effective in the treatment 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 42229-5

FAST RELIEF 100% GUARANTEED

Relieves Itching and Burning

Also Cures Athlete's Foot and Ringworm

Distributed by:



Trifecta Pharmaceuticals USA TM



101 NE Third Avenue Suite 1500



Ft. Lauderdale, FL 33301 USA



www.trifecta-pharma.com

Section 50565-1

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

Section 51727-6

Inactive ingredients Carbomer, cetostearyl alcohol, dimethyl sulfoxide, edetate disodium, ethylparaben, glycerol, glyceryl distearate, mineral oil, peregal-o, purified water, stearic acid, triethanolamine, petrolatum.

Warnings

For external use only. Do not use if the safety-sealed tube is punctured or damaged.

Do not use on children under 2 years of age unless directed by a healthcare professional. When using this product avoid contact with the eyes.

Stop use and ask a healthcare professional if • irritation occurs or if there is no improvement within 4 weeks (for athlete's foot and ringworm) • Irritation occurs, or if there is no improvement within 2 weeks (for jock itch).

Packaging

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%

Other Information

• Store at 15° - 30° c (59° - 86° f) • Lot number and expiration date see crimp of tube or see box. • To open: Unscrew cap, tear safety seal off.

You may report serious side effects to: [email protected]


Structured Label Content

Uses
  • proven clinically effective in the treatment 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 42229-5 (42229-5)

FAST RELIEF 100% GUARANTEED

Relieves Itching and Burning

Also Cures Athlete's Foot and Ringworm

Distributed by:



Trifecta Pharmaceuticals USA TM



101 NE Third Avenue Suite 1500



Ft. Lauderdale, FL 33301 USA



www.trifecta-pharma.com

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

Inactive ingredients Carbomer, cetostearyl alcohol, dimethyl sulfoxide, edetate disodium, ethylparaben, glycerol, glyceryl distearate, mineral oil, peregal-o, purified water, stearic acid, triethanolamine, petrolatum.

Purpose

Anti-Fungal

Warnings

For external use only. Do not use if the safety-sealed tube is punctured or damaged.

Do not use on children under 2 years of age unless directed by a healthcare professional. When using this product avoid contact with the eyes.

Stop use and ask a healthcare professional if • irritation occurs or if there is no improvement within 4 weeks (for athlete's foot and ringworm) • Irritation occurs, or if there is no improvement within 2 weeks (for jock itch).

Packaging

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%

Other Information

• Store at 15° - 30° c (59° - 86° f) • Lot number and expiration date see crimp of tube or see box. • To open: Unscrew cap, tear safety seal off.

You may report serious side effects to: [email protected]


Advanced Ingredient Data


Raw Label Data

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