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  5. Label Information: Miconazole Nitrate

FDA Label for Miconazole Nitrate

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. OTC - DO NOT USE
    7. OTC - WHEN USING
    8. STOP USE AND ASK A DOCTOR IF
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS OR COMMENTS?
    14. PRINCIPAL DISPLAY PANEL - 28 G TUBE CARTON

Miconazole Nitrate Product Label

The following document was submitted to the FDA by the labeler of this product H2-pharma, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts

Distributed by: H2-Pharma, LLC
Montgomery, AL 36117


Active Ingredient



Miconazole nitrate USP, 2%


Purpose



Antifungal


Uses



  • proven clinically effective in the treatment of most athlete's foot, jock itch, and ringworm
  • for effective relief of itching, scaling, cracking, burning, and discomfort

Warnings



For external use only


Otc - Do Not Use



Do not use on children under 2 years of age unless directed by a doctor.


Otc - When Using



When using this product, avoid contact with the eyes.


Stop Use And Ask A Doctor If



  • irritation occurs
  • there is no improvement within 4 weeks (for athlete's foot and ringworm) or within 2 weeks (for jock itch)

Otc - Keep Out Of Reach Of Children



Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.


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 doctor
  • supervise children in the use of this product
  • for athlete's foot: pay special attention to the 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 lasts longer, contact a doctor
  • this product is not effective on the scalp or nails

Other Information



  • do not use if foil seal on tube opening is broken or missing
  • to open tube: unscrew cap, lift tab, and pull to remove foil seal prior to use
  • store at room temperature 15°-30°C (59°-86°F)
  • before using any medication, read all label directions. Keep carton, it contains important information.

Inactive Ingredients



benzoic acid, butylated hydroxyanisole, mineral oil, oleoyl polyoxylglycerides, pegoxol 7 stearate, purified water


Questions Or Comments?



Call 1-877-753-3935 Monday-Friday 9AM-5PM EST


Principal Display Panel - 28 G Tube Carton



Miconazole Nitrate Cream USP, 2%
Antifungal Cream

NDC 61269-735-56
*Compare to the active ingredient in
Micatin® Antifungal Cream

Soothes itching, scaling, cracking, and burning | Cures most athlete's foot, jock itch, and ringworm | Clinically proven

Net wt. 1 oz (28 g)

H2 pharma

Principal Display Panel - 28 g Tube Carton - miconazole 01

Principal Display Panel - 28 g Tube Carton - miconazole 01


* Please review the disclaimer below.