QUINSANA ATHLETES FOOT ANTI FUNGAL (TOLNAFTATE) POWDER [PROFOOT, INC.]

QUINSANA ATHLETES FOOT ANTI FUNGAL (TOLNAFTATE) POWDER [PROFOOT, INC.]
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NDC 29784-141-85
Set ID acc2ce55-aa30-4c82-9e72-93a0a5e85ecf
Category HUMAN OTC DRUG LABEL
Packager Profoot, Inc.
Generic Name
Product Class
Product Number
Application Number PART333C
  • Drug Facts

  • Active Ingredient

    Tolnaftate, 1%

    Purpose

    Antifungal

  • Uses

    • Cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis)
    • Effectively relieves itching, cracking, and burning
  • Warnings

    For external use only

    Ask a doctor before use

    • on children under 2 years of age

    When using this product

    • avoid contact with eyes

    Stop use and ask a doctor if

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

    Keep out of reach of children.

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

  • Directions

    • Wash affected area and dry thoroughly.
    • Apply a thin layer of the product over time indicated.
    • Supervise children in the use of this product. For athlete's foot and ringworm: Use twice daily (morning and night) for 4 weeks or as directed by physician. Pay special attention to spaces between the toes. Wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.  For jock itch: Use daily for 2 weeks. 
    • Clean the affected area and dry thoroughly.
    • This product is not effective on the scalp or nails.
  • Inactive ingredients

    Talc, Cornstarch.

  • Package Labeling:

    Label- Quinsana Antifungal Powder 3oz

  • INGREDIENTS AND APPEARANCE
    QUINSANA ATHLETES FOOT ANTI FUNGAL 
    tolnaftate powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29784-141
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    TALC (UNII: 7SEV7J4R1U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29784-141-8585 g in 1 BOTTLE; Type 0: Not a Combination Product05/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C05/01/2019
    Labeler - Profoot, Inc. (107570900)

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