Label: HERBAL BALM- methyl salicylate, menthol and cream

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

Drug Label Information

Updated November 20, 2023

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  • Drug Facts

  • Active Ingredients

    Methyl Salicylate 20.7%

    Menthol 15.6%

    Camphor 3.1%

  • Purpose

    External analgesic

  • Uses

    For temporary relief of minor aches and pains of muscles and joints due to:

    • arthritis
    • strains
    • bruises
    • sprains
    • simple backache
  • Warnings

    For external use only

    Do not use

    • on wounds

    • irritated or damaged skin

    • sensative skin

    • with a heating pad

    • if pregnant

    • with, or as the same time as, other external analgesic products

    • if allergic to aspirin or salicylates

    • if allergic to any ingredients of this prodcut

    When using this product

    • avoid contact with eyes
    • do not bandage tightly
    • do not apply to wounds or damaged skin
    • do not use 1 hour before or after bathing

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days
    • symptoms clear up and occur again within a few days
    • excessive irritation of the skin develops
    • redness is present
    • side effects occur

    If pregnant, ask a health professional before use.

    Keep out of reach of childrento avoid accidental poisoning

    In case of overdose, get medical help or contact a Poison Control Center right away.

    Do not use otherwise than as directed.

  • Directions

    • Apply to the affected area. Rub well on affected area.
    • Repeat 2 times daily.
    •  Children under 2 years of age: Do not use or consult a doctor.
  • Other Information

    • Store at room temperature, 20 to 25°C (68 to 77°F)
  • Other Ingredients

    Eucalyptus Oil, Lavender Oil, Vaseline, White beeswax.

  • Questions or Comments?

    Tel: 714-531-2020

    Web: tnduocthao.com

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    label

  • INGREDIENTS AND APPEARANCE
    HERBAL BALM 
    methyl salicylate, menthol and cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82198-0007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL156 mg  in 1 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE207 mg  in 1 g
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)31 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    Product Characteristics
    ColoryellowScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82198-0007-150 g in 1 JAR; Type 0: Not a Combination Product10/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01710/01/2022
    Labeler - Big 5 Nutrition LLC (114574559)
    Establishment
    NameAddressID/FEIBusiness Operations
    Taiwan Shuenn-Ann Biotechnology Pharmaceutical Co., Ltd.656348265manufacture(82198-0007)
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