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  5. Label Information: Tolnaftate D

FDA Label for Tolnaftate D

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. WHEN USING THIS PRODUCT
    6. STOP USE AND ASK A DOCTOR IF
    7. DO NOT USE
    8. KEEP OUT OF REACH OF CHILDREN
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. QUESTIONS?
    13. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tolnaftate D Product Label

The following document was submitted to the FDA by the labeler of this product Nexmed (usa), Inc.. 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.

Active Ingredient



Tolnaftate


Purpose



Antifungal


Uses



  • Proven clinically effective in the treatment of athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)
  • Proven effective in the prevention of athlete’s foot
  • Effectively soothes and relieves itching associated with jock itch, scaly skin between the toes and burning feet

Warnings



For external use only


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 (for jock itch) and 4 weeks for (athlete’s foot and ringworm)

Do Not Use



on children under 2 years of age except under the advice and supervision of a doctor


Keep Out Of Reach Of Children



If swallowed, get medical help or contact a Poison Control Center right away


Directions



  • Clean the affected area and dry thoroughly
  • Apply a thin layer over affected area twice a daily (morning and night) or as directed by a doctor
  • Supervise children in the use of this product
  • For athlete’s foot, pay 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

Other Information



  • Store between 20⁰ and 25⁰C (68⁰ to 77⁰F)
  • Lot No. and Exp. Date: see box or see crimp of tube
  • Keep box for complete instructions and labeling

Inactive Ingredients



cetyl  alcohol, dodecyl-2-N N-dimethylaminopropionate hydrochloride, methylparaben, mineral oil, ceteth-10, propylene glycol, propylparaben, purified water, sorbitan monostearate, stearyl alcohol


Questions?



Call 858-222-8041, Mon-Fri, 8:30 AM - 5:30PM (PST)


Package Label.Principal Display Panel



Image of carton label - carton

Image of carton label - carton


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