Label: O24 PAIN NEUTRALIZER- camphor 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 February 19, 2018

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  • ACTIVE INGREDIENT

    Camphor 3.1%

  • PURPOSE

    Camphor 3.1%.............................External Analgesic

  • INDICATIONS & USAGE

    temporarily relieves minor aches and pains of muscles and joints associated with:

    • simple backache
    • arthritis
    • strains
    • bruises
    • sprains
  • WARNINGS

    For External Use Only.

  • DO NOT USE

    Do Not Use

    • For arthritis-like conditions in children under 2.
    • on wounds, damaged, broken or irritated skin.
  • WHEN USING

    When Using This Product

    • use only as directed.
    • do not bandage tightly.
    • avoid contact with the eyes and mucous membranes.
  • STOP USE

    Stop Use and Ask Doctor If

    • condition worsens
    • symptoms last more than 7 days
    • symptoms clear up and come back in a few days
  • KEEP OUT OF REACH OF CHILDREN

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

  • PREGNANCY OR BREAST FEEDING

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

  • DOSAGE & ADMINISTRATION

    • adults and children 2 years of age and older: apply to (gently wipe) affected area not more than 3 to 4 times daily
    • children under 2 years of age: consult a physician
  • INACTIVE INGREDIENT

    Aloe Barbadensis Leaf Juice, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Limon (Lemon) Peel Oil, Eucalyptus Globulus Leaf Oil, Mentha arvensis (Peppermint Leaf) Oil, Rosmarinus Ofcinalis Leaf (Rosemary) Oil

  • DESCRIPTION

    Distributed by

    O24 TM Naturals, LLC

    306 Hallmark Dr.,

    Arlington, TX 76011

    Questions?

    Call TOLL-FREE:

    1.866.902.8594 or visit us at:

    www.O24zone.com

    O24 TM is a Registered Trademark

    of O24 TM Naturals, LLC.

  • PRINCIPAL DISPLAY PANEL

    024 TMNaturals

    024 TM

    Pain Neutralizer

    Topical Analgesic

    Penetrating Pain Relief

    for the temporary relieft of minor aches & pains associated with arthritis, strains, backaches, and bruises

    10 Towelettes

    (4 in x 6 in / 10.2 cm x 15.2 cm)

    O24Towelettes

  • INGREDIENTS AND APPEARANCE
    O24 PAIN NEUTRALIZER 
    camphor liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58265-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)3.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    LEMON OIL (UNII: I9GRO824LL)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    MENTHA ARVENSIS FLOWER OIL (UNII: Q129Z1W6Y2)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58265-004-1010 in 1 CARTON02/19/2018
    12 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/19/2018
    Labeler - O24 Naturals LLC (962526559)
    Establishment
    NameAddressID/FEIBusiness Operations
    D&d Essential Oils, Llc.,051894458manufacture(58265-004)
    Establishment
    NameAddressID/FEIBusiness Operations
    Biomed Laboratories LLC055329696label(58265-004)
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