CLOTRIMAZOLE SOLUTION [DELSAM PHARMA LLC]

CLOTRIMAZOLE SOLUTION [DELSAM PHARMA LLC]
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NDC 72570-110-30
Set ID 762a93d9-e808-470c-a939-02751f3bded9
Category HUMAN OTC DRUG LABEL
Packager Delsam Pharma Llc
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
  • Drug Facts

  • Active Ingredient:

    Clotrimazole USP 1%

  • Purpose

    Antifungal

  • Uses

    • Cures most athlete's foot, jock itch and ringworm infections

    • Relieves itching, burning, cracking, scaling and discomfort which accompany these conditions

  • Warnings

    • For external use only
    • Do not use on children under 2 years of age unless directed by a doctor.
    • When using this product avoid contact with eyes. If contact occurs rinse eyes thoroughly with water.
    • Stop use and ask a doctor if irritation occurs or there is no improvement within 4 weeks 
  • 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 to the affected area twice daily (morning and night) or as directed by your doctor

    • Supervise children in the use of this product

    • For athlete's foot: pay special 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

    • if condition persists longer, consult your doctor

  • Inactive Ingredient:

    Polyethylene Glycol

  • Other Information:

    Store at room temperature (68° to 77°F)

    Retain this carton for future reference

  • Questions or Comments?

    1-866-826-1306 between 9 am and 4 pm EST, Monday-Friday.

  • SPL UNCLASSIFIED SECTION

    • Relieves itching & burning
    • Greaseless
    • Non-Staining

    *Compare to the active ingredient in Lotrimin®AF

    All trademarks are property of their respective owners. This product is not affiliated with the makers/owners of Lotrimin®AF

    Distributed by:

    Delsam Pharma Llc

    Bronx, Newyork 10467.

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    CLOTRIMAZOLE 
    clotrimazole solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72570-110
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72570-110-301 in 1 CARTON10/25/2018
    130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C10/25/2018
    Labeler - Delsam Pharma Llc (081369679)

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