Label: KOFAL- methyl salicylate ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 22, 2024

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  • Active ingredients & Purpose

    Purpose

    External Analgesic

    Active ingredient Purpose
    Methyl Salicylate 10.5%.............................External Analgesic

  • Uses

    For the temporary relief of minor aches and pains of muscles and joints associated with:

    • simple backache
    • arthritis
    • strains
    • sprains
  • Warnings

    For external use only. Avoid contact with the eyes.

    Do not use

    • on broken or irritated skin
    • with a tight bandage
    • with a heating pad

    Stop use and ask doctor immediately if

    • condition worsens
    • symptoms persist for more than 7 days or clear up and occur again within a few days
    • excessive skin irritation occurs

    If pregnant or breast-feeding,

    ask a health care professional before use.

    Keep out of reach of children.

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

  • Directions

    • adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
    • children under 12 years of age: consult a doctor
  • Other information

    • store between 59° to 86°F (15° to 25°C)
    • do not use if clear seal over jar is broken, torn or missing
  • Inactive ingredients

    camphor, menthol, methylparaben, paraffin, petrolatum, propylparaben.

  • Questions or comments?

    1-866-359-3478 M-F 9 AM - 5 PM EST or www.pharmadel.com

  • Distributed by/ Distribuido por:

    Pharmadel LLC, Georgetown, DE 199747

  • Package Label & Principal Display Panel

    PDP Kofal 2oz

  • INGREDIENTS AND APPEARANCE
    KOFAL 
    methyl salicylate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-109
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE10.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CAMPHOR, (-)- (UNII: 213N3S8275)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55758-109-0260 g in 1 JAR; Type 0: Not a Combination Product01/21/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01701/21/2020
    Labeler - Pharmadel LLC (030129680)
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