Label: O24 ESSENTIAL OIL PAIN RELIEVING- camphor spray

  • Category: HUMAN OTC DRUG LABEL

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 January 26, 2012

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  • ACTIVE INGREDIENT

    camphor 3.1%

  • PURPOSE

    Topical Analgesic

  • INDICATIONS & USAGE

    For the temporary relief of minor aches and pains of muscles and joints associated with simple backaches, arthritis, strains, bruises and sprains.

  • WARNINGS

    For external use only.

  • WHEN USING

    When using this product

    • avoid contact with eyes
  • DO NOT USE

    Do not

    • apply to wounds or damaged skin
    • bandage tightly
  • STOP USE

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days or clear up and occur again within a few days
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast feeding, ask a health professional before use.


  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • adults and children 2 years of age and older: Spray the affected area with 3-4 sprays up to 4 times per day for maximum relief
    • after applying, wait 10 minutes and then wash area if desire to remove scent.  This will not decrease effectiveness.
    • children under 2 years of age: consult a physician
  • STORAGE AND HANDLING

    store in a cool, dry place

  • INACTIVE INGREDIENT

    Aloe Vera Oil, Eucalyptus Globulus Leaf Oil, Lemon Peel Oil (Citrus Medica Limonum), Orange Oil (Citrus Aurantium Dulcis), Peppermint Oil (Mentha Piperita), Rosemary Leaf Oil (Rosmarinus Officinalis)

  • QUESTIONS

    Questions or comments?

    1.877.310.4173 9:00am-5:00pm EST M-F

    allnaturalpainmanagement.com

  • PRINCIPAL DISPLAY PANEL

    O24 Spray Bottle Label

  • INGREDIENTS AND APPEARANCE
    O24  ESSENTIAL OIL PAIN RELIEVING
    camphor spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76433-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)1 mL  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    LEMON OIL (UNII: I9GRO824LL)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76433-004-3030 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/01/2012
    Labeler - Revive Bioscience, Inc. (248262920)
    Registrant - Revive Bioscience, Inc. (248262920)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sigan Industries255106239manufacture
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