O24 ESSENTIAL OIL PAIN RELIEVING (CAMPHOR) SPRAY [REVIVE BIOSCIENCE, INC.]

O24 ESSENTIAL OIL PAIN RELIEVING (CAMPHOR) SPRAY [REVIVE BIOSCIENCE, INC.]
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NDC 76433-004-30
Set ID 43b173dd-d541-406e-9864-779f86f7a6ea
Category HUMAN OTC DRUG LABEL
Packager Revive Bioscience, Inc.
Generic Name
Product Class
Product Number
Application Number PART348
  • 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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