CAMPHOR OINTMENT [WORLD PERFUMES, INC]

CAMPHOR OINTMENT [WORLD PERFUMES, INC]
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NDC 10095-003-01
Set ID 421ff22c-6521-463b-b324-173cc234e1f7
Category HUMAN OTC DRUG LABEL
Packager World Perfumes, Inc
Generic Name
Product Class
Product Number
Application Number PART348
  • 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:10095-003
    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:10095-003-012 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 - World Perfumes, Inc (101312044)
    Establishment
    NameAddressID/FEIBusiness Operations
    World Perfumes, Inc101312044manufacture(10095-003)

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