Miconazole Nitrate 2% Cream Antifungal Cream
FDA Label NDC 68788-8845

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Preferred Pharmaceuticals Inc. for the product Miconazole Nitrate 2% Cream Antifungal (NDC 68788-8845). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, otc - keep out of reach of children, uses, warnings, directions, inactive ingredient, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Miconazole Nitrate 2%

Purpose

Anti-Fungal

Otc - Keep Out Of Reach Of Children

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

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.

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).

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.

Inactive Ingredient

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

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]

Other

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

Relabeled By: Preferred Pharmaceuticals Inc.

68788-8845-3

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