Label: CAMPHOR ointment

  • 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 May 5, 2015

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  • ACTIVE INGREDIENT

    Active Ingredients ............. Purpose

    Camphor 10% ............. Topical Analgesic

  • PURPOSE

    Uses

    • Temporary relief of minor pain
    • Rheumatism
    • Muscular Aches
    • Arthritis
    • Backache
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children.

  • INDICATIONS & USAGE

    Camphor Ointment

    External Use Only

    Temporary relief of minor pains:

    Muscular Aches | Arthritis

    Rheumatism | Backache

  • DOSAGE & ADMINISTRATION

    Directions - Adults and children 10 years of age and older: apply in affected area not more than 3 times daily.

  • WARNINGS

    Warning - For external use only.

    In case of accidental ingestion, get help or contact a poison control center immediately.

    Do not use

    • on irritated skin
    • in or near eyes or mucous membranes
    • on wounds or damaged skin
    • if prone to allergic reaction from any ingredient
    • on large area of the body

    Ask a doctor or pharmacist before use if you are taking any other medication or drinking alcohol. Stop use and ask a doctor if condition worsens or clears up and occurs again, if symptoms persist for more than 7 days or irritation or severe burning occurs. If pregnant or breast-feeding ask a health professional before use. Keep at room temperature.

  • INACTIVE INGREDIENT

    Inactive Ingredients Petrolatum

  • PRINCIPAL DISPLAY PANEL

    label image

  • INGREDIENTS AND APPEARANCE
    CAMPHOR 
    camphor ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59561-703
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    ALCOHOL (UNII: 3K9958V90M)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59561-703-022 g in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/05/2015
    Labeler - Caribe Natural, Inc (624210480)
    Establishment
    NameAddressID/FEIBusiness Operations
    World Perfumes, Inc101312044manufacture(59561-703)
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