Label: EASY JOINT- camphor spray

  • 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 December 1, 2017

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  • ACTIVE INGREDIENT

    Camphor 3.1%

  • PURPOSE

    Camphor 3.1%.........................................Topical 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

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

    When Using This Product

    • use only as directed.
    • do not bandage tightly.
    • avoid contact with eyes or mucous membranes.

    Stop And Ask Doctor If

    • condition worsens
    • symptoms last more than 7 days
    • symptoms clear up and com back in a few days

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

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

  • DOSAGE & ADMINISTRATION

    • adults and children 2 yrs of age and older: apply to affected area not more than 3 to 4 times daily
    • children under 2 yrs 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) Oil, Rosmarinus Officinalis Leaf (Rosemary) Oil

  • QUESTIONS

    (855) 303-2430

    solairenutraceuticals.com

  • DESCRIPTION

    Distributed by Solaire Nutraceuticals

    16 W. Madison St. Baltimore, MD 21202

    solairenutraceuticals.com

    4O4SO24PN

  • PRINCIPAL DISPLAY PANEL

    SOLAIRE

    NUTRACEUTICALS

    EASY JOINT TM

    Pain Relief Spray

    Spray Bottle

    1f.l oz (30 mL)

    EasyJointBox

  • INGREDIENTS AND APPEARANCE
    EASY JOINT 
    camphor spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58265-003
    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 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    LEMON OIL (UNII: I9GRO824LL)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    MENTHA ARVENSIS FLOWER OIL (UNII: Q129Z1W6Y2)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58265-003-301 in 1 CARTON12/01/2017
    130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/01/2017
    Labeler - O24 Naturals, LLC (962526559)
    Establishment
    NameAddressID/FEIBusiness Operations
    D&d Essential Oils, Llc.,051894458manufacture(58265-003)
    Establishment
    NameAddressID/FEIBusiness Operations
    Biomed Laboratories LLC055329696label(58265-003)
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