CLOTRIMAZOLE CREAM [DELSAM PHARMA LLC]

CLOTRIMAZOLE CREAM [DELSAM PHARMA LLC]
PDF | XML

NDC 72570-105-30
Set ID becd0353-56a7-4c4c-8b7a-1363ef2eefa5
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

    • 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 the eyes 

    Stop use and ask a doctor if • irritation occurs • there is no improvement within 4 weeks (for athlete's foot and ring worm) or 2 weeks (for jock itch)

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    • wash the affected area and dry thoroughly

    • apply a thin layer over affected area twice daily (morning and night)

    • 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 persists longer, consult a doctor • this product is not effective on the scalp or nails

  • Inactive ingredients

    Cetostearyl alcohol, Cetomacrogol 1000, Micro wax, Light liquid paraffin, Paraffin wax, Chlorocresol, Propylene Glycol, Purified water.

  • Other information

    Do not use if seal is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal

    • store at temperature not exceeding 30°C (86°F). Do not freeze. • See crimp of tube or carton for Lot Number and Expiration Date

  • Questions or comments?

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

  • SPL UNCLASSIFIED SECTION

    Relieves Itching & Burning, Relieves Cracking and Scaling, Grease less, Non-Staining

    Compared to the active ingredient in Lotrimin AF

    ANTIFUNGAL

    Cures Most Athlete's Foot

    Distributed by:

    Delsam Pharma Llc

    Bronx, Newyork 10467.

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    CLOTRIMAZOLE 
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72570-105
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETETH-20 (UNII: I835H2IHHX)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    CHLOROCRESOL (UNII: 36W53O7109)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorwhite (white to off white) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72570-105-301 in 1 CARTON09/25/2018
    130 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C09/25/2018
    Labeler - Delsam Pharma Llc (081369679)

Related Drugs