Label: CLOTRIMAZOLE solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 Label Information

Updated September 24, 2018

If you are a consumer or patient please visit this version.

  • 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)