Label: CVS PAIN RELIEVING- camphor 5.5% menthol 16% lotion

  • 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 December 19, 2022

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  • ACTIVE INGREDIENT

    Camphor 5.5 %

    Menthol 16 %

  • PURPOSE

    Pain Relieving Lotion

  • INDICATIONS & USAGE

    For the temporary relief of minor aches and pains of muscles and joints associated with

    Arthritis

    simple backache

    strains

    sprains

    bruises

    Provides penetrating pain relief

  • WARNINGS

    For extranal use only

    avoid contact with eyes and mucous membranes

    do not bandage tightly

    do not use with a heating pad, medicated patch or other of local heat

    do not apply to wounds or damaged, broken or irritated skin

    condition worsens or irritation develops

    pain, swelling or blistering develops where product was applied

    redness or severe burning develops when product was applied

    symptoms persist for more than 7 days or clear up and occur again within a few days

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

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

  • DOSAGE & ADMINISTRATION

    Adults and children 12 years of age and older:

    Apply to affected area not more than 3 to 4 times daily

    Wash hands with soap and water after use if product comes with hands

    Children under 12 years of age

    Ask a doctor

  • OTHER SAFETY INFORMATION

    store between 20° - 25°C (68° - 77°F)

  • INACTIVE INGREDIENT

    Carbomer, Clove Oil, Disodium EDTA, Eucalyptus Oil, Pentylene Glycol, Peppermint Oil, Phenoxyethanol, Polysorbate 80, SD Alcohol 40 B, Sorbitan Oleate, Tocopherol Acetate, Water

  • PRINCIPAL DISPLAY PANEL

    Package Carton

  • INGREDIENTS AND APPEARANCE
    CVS PAIN RELIEVING 
    camphor 5.5% menthol 16% lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-885
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)16 mg  in 1 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    CLOVE OIL (UNII: 578389D6D0)  
    ALCOHOL (UNII: 3K9958V90M)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51316-885-1672 g in 1 TUBE; Type 0: Not a Combination Product12/19/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/19/2022
    Labeler - CVS (062312574)
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