Label: JOSEPHS LION- camphor and menthol lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 November 14, 2019

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  • ACTIVE INGREDIENT

    Active ingredients
    Camphor 3.5%
    Menthol 5%

  • PURPOSE

    Purpose
    External analgesic

  • WARNINGS

    Warnings
    For external use only

  • DO NOT USE


    Do not use

    • on wounds
    • on irritated or damaged skin
    • otherwise than as directed
  • WHEN USING

    When using this product

    • avoid contact with the eyes or mucous membranes
    • do not bandage tightly
  • STOP USE

    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

    when using for pain of arthritis:

    • pain persists for more than 10 days
    • redness is present
    • in conditions affecting children under 12 years of age
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children to avoid accidental poisoning.
    If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • adults and children 3 years of age and older: apply to affected area not more than 3 to 4 times daily.
    • children under 3 years of age: do not use, consult a physician.
    • refer to the above warnings; use otherwise than as directed may be dangerous.
  • STORAGE AND HANDLING

    Other information
    keep container tightly closed
    store at 15E to 30 C (59 to 86 F)

  • INACTIVE INGREDIENT

    Inactive ingredients
    Anise oil, cajuput oil, lavender oil, methyl salicylate,and mineral oil.

  • QUESTIONS

    Questions or comments? (888) 221-3496 M-F 9 am to 5 pm

  • INDICATIONS & USAGE

    Uses
    For the temporary relief of minor aches and pains of muscles and joints due to:
    simple backache, arthritis, strains, bruises, sprains

  • PRINCIPAL DISPLAY PANEL

    JOSEPH’S LION OIL, PAIN RELIEVING LOTION, NDC 53196-001-01, 2 fl oz (60 mL)
    Box1.jpg

  • INGREDIENTS AND APPEARANCE
    JOSEPHS LION 
    camphor and menthol lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53196-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)3.5 g  in 100 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANISE OIL (UNII: 6Y89129C8H)  
    CAJUPUT OIL (UNII: J3TO6BUQ37)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53196-001-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product08/28/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/28/2012
    Labeler - CHAN YAT HING MEDICINE FACTORY (680069367)
    Registrant - CHAN YAT HING MEDICINE FACTORY (680069367)
    Establishment
    NameAddressID/FEIBusiness Operations
    CHAN YAT HING MEDICINE FACTORY680069367manufacture(53196-001)
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