OTC Medication Information: MICONAZOLE Nitrate 2% Cream ANTIFUNGAL
MICONAZOLE NITRATE 2% CREAM ANTIFUNGAL- miconazole nitrate cream
Trifecta Pharmaceuticals Usa Llc
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Facts
Active ingredient
Miconazole Nitrate 2%
Purpose
Anti-Fungal
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 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: QC@trifecta-pharma.com
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
Packaging
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Labeler — Trifecta Pharmaceuticals Usa Llc (079424163) |
Revised: 01/2021 Trifecta Pharmaceuticals Usa Llc
Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.
https://otclabels.com/lib/otc/otc-meds/miconazole-nitrate-2-cream-antifungal/