Label: MEIJER PAIN RELIEVING ANALGESIC (camphor- synthetic and menthol, unspecified form lotion

  • NDC Code(s): 79481-0051-1
  • Packager: Meijer Distribution, INC
  • 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 22, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientPurpose
    Camphor 5.5%Topical analgesic
    Menthol 16%Topical analgesic
  • Use

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

  • Warnings

    For external use only

    Flammable: Keep away from fire or flame

    Do not use: if you ever had an allergic reaction to this product or any of its ingredients.

    When using this product

    ⬥
    avoid contact with eyes
    ⬥
    do not apply to wounds or damaged skin
    ⬥
    do not bandage tightly
    ⬥
    do not use in large quantities
    ⬥
    do not use with heating pads, medicated patches or heating devices.

    Stop use and ask a doctor if

    ⬥
    condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
    ⬥
    pain, swelling, blistering develops where product is used
    ⬥
    redness or severe burning sensation develops where product is used.

    If you are pregnant or nursing, seek the advice of a health professional before using.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    Adults and children 12 years of age and older:

    ⬥
    apply to affected area not more than 3 to 4 times daily.

    Children under 12 years of age: consult a doctor.

  • Other information

    ⬥
    protect the product in this container from excessive heat and direct sun
    ⬥
    store at room temperature.
  • Inactive ingredients

    alcohol denat., aminomethyl propanol, boswellia serrata resin extract, carbomer, disodium EDTA, ethylhexylglycerin, eucalyptus polybractea leaf oil, Eugenia caryophyllus (clove) flower oil, fragrance, glycerin, linum ultatissimum (linseed) seed oil, mentha piperita (peppermint) oil, menthoxypropanediol, pentylene glycol, phenoxyethanol, polysorbate 80, rosmarinus officinalis (rosemary) leaf oil, thymus zygis oil, vanillyl butyl ether, water.

  • Questions or comments?

    1-866-567-8600

  • SPL UNCLASSIFIED SECTION

    DIST. BY MEIJER
    DISTRIBUTION, INC.
    GRAND RAPIDS, MI 49544

  • PRINCIPAL DISPLAY PANEL - 77 g Tube Label

    meijer®

    Compare to
    AleveX® Pain Relieving
    Lotion Active
    Ingredients*

    pain
    relieving
    lotion

    Camphor 5.5%
    Menthol 16%

    Topical Analgesic

    WITH MAXIMUM
    STRENGTH MENTHOL

    NET WT 2.7 OZ (77g)

    PRINCIPAL DISPLAY PANEL - 77 g Tube Label
  • INGREDIENTS AND APPEARANCE
    MEIJER PAIN RELIEVING   ANALGESIC
    camphor (synthetic) and menthol, unspecified form lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79481-0051
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)55 mg  in 1 g
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM160 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Eucalyptus polybractea leaf oil (UNII: J1XGA6WROO)  
    CLOVE OIL (UNII: 578389D6D0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LINSEED OIL (UNII: 84XB4DV00W)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    3-((L-MENTHYL)OXY)PROPANE-1,2-DIOL (UNII: KD6TZ2QICH)  
    Pentylene glycol (UNII: 50C1307PZG)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Polysorbate 80 (UNII: 6OZP39ZG8H)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    SPANISH THYME OIL (UNII: U14667H96E)  
    Vanillyl butyl ether (UNII: S2ULN37C9R)  
    Water (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79481-0051-177 g in 1 TUBE; Type 0: Not a Combination Product12/05/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/05/2022
    Labeler - Meijer Distribution, INC (006959555)
    Registrant - Garcoa, Inc. (036464697)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sigan Industries INC255106239MANUFACTURE(79481-0051)
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