Label: LEADER CAMPHOR SPIRIT (camphor- natural liquid

  • 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 August 30, 2018

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  • ACTIVE INGREDIENT

    Camphor 10%

  • INDICATIONS & USAGE

    For the temporary relief of minor aches, muscle and joint pain associated with arthritis, strains, bruises and simple backache.

  • WARNINGS

    For external use only.

    Do not drink. If swallowed, immediately give 3 or 4 glasses of water. Do not induce vomiting. If vomiting occurs, give fluids again. Do not give anything by mouth to an unconscious or convulsing person. Get medical attention immediately.

    Avoid contact with eyes or mucous membranes.

    Do not apply to irritated skin.

  • PURPOSE

    Counterirritant

  • KEEP OUT OF REACH OF CHILDREN

    In case of accidental ingestion, seek professional assistance or contact a Poison Control Center right away. In case of eye contact, flush eyes with running water for 15 minutes, get medical attention.

  • INACTIVE INGREDIENT

    Alcohol 84%, Purified Water

  • DOSAGE & ADMINISTRATION

    (dilute 3 parts olive oil and mix well)


    Adults and children 2 yrs, and older. Apply to the affected area no more than 3 or 4 times daily.

    Children under 2 yrs of age: consult a doctor before use.

  • PRINCIPAL DISPLAY PANEL

    Leader Camphor SPirit

  • INGREDIENTS AND APPEARANCE
    LEADER CAMPHOR SPIRIT 
    camphor (natural) liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-009
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37205-009-1659 mL in 1 BOTTLE; Type 0: Not a Combination Product08/30/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/30/2018
    Labeler - Cardinal Health (097537435)
    Registrant - Humco Holding Group, Inc (825672884)
    Establishment
    NameAddressID/FEIBusiness Operations
    Humco Holding Group, Inc825672884manufacture(37205-009) , analysis(37205-009) , pack(37205-009) , label(37205-009)
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