Label: CAMPHOR SPIRIT- camphor 10% 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 June 20, 2020

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  • SPL UNCLASSIFIED SECTION


    Drug Facts

  • Active Ingredient

    Camphor 10%

  • Purpose

    Counterirritant

  • Use

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

  • Warnings

    For external use only.

    Do not drink. If swallowed, immediately give 3 or 4 glases 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.

  • When using this product

    Do not bandage tightly.

  • Discontinue use and consult a doctor if

    condition worsens, or if excesive irritation develops.

    symptoms persit for more than 7 days, or clear up and occur again within a few days.

  • 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.

  • Directions

    (dilute 3 parts olive oil and mix well)

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

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

  • Other Information

    Flammable: Keep away from spark, heat and flame.

  • Inactive ingredients

    Alcohol 84%, Purified Water

  • Sunmark Label

    label

  • Leader Label

    LDRCam.jpg

  • Quality Choice Label

    QC

  • DDM Label

    DDM

  • INGREDIENTS AND APPEARANCE
    CAMPHOR SPIRIT 
    camphor 10% liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0395-9112
    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:0395-9112-9259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/12/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/01/2008
    Labeler - Humco Holding Group, Inc. (825672884)
    Registrant - Humco Holding Group, Inc. (825672884)
    Establishment
    NameAddressID/FEIBusiness Operations
    Humco Holding Group, Inc.825672884manufacture(0395-9112) , analysis(0395-9112) , pack(0395-9112) , label(0395-9112)
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