Label: LEADER CAMPHOR SPIRIT (camphor- natural liquid

  • NDC Code(s): 70000-0396-1
  • Packager: Cardinal Health, 110 dba Leader
  • 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 March 17, 2022

If you are a consumer or patient please visit this version.

  • DOSAGE & ADMINISTRATION

    (Dillute with 3 parts olive oil and mix well)

    Adults and children 2 yrs. and older apply to the affected area not more than 3 or 4 times daily.

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

  • INACTIVE INGREDIENT

    Alcohol 84%, Purified Water

  • 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.

  • PURPOSE

    External Analgesic

  • 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.

  • INDICATIONS & USAGE

    For the temporary relief of minor aches, muscle and jooint pain associated with artritis, strains, bruises and simple backache

  • ACTIVE INGREDIENT

    Camphor 10%

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    LEADER CAMPHOR SPIRIT 
    camphor (natural) liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0396
    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
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0396-159 mL in 1 BOTTLE; Type 0: Not a Combination Product12/17/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/17/2018
    Labeler - Cardinal Health, 110 dba Leader (063997360)
    Registrant - Pharma Nobis, LLC (118564114)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Nobis, LLC118564114manufacture(70000-0396) , analysis(70000-0396) , pack(70000-0396) , label(70000-0396)