Label: RELIEVE AND RELAX PAIN RELIEVING (camphor- synthetic, menthol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 19, 2023

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  • DRUG FACTS

  • Active Ingredients

    Camphor 4.0% w/w

    Menthol 10.0% w/w

    Purpose

    Topical Analgesic

  • Uses:

    Temporarily relieves the 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.

    • Avoid getting into eyes or on mucous membranes.

    • If conditions worsens, or if symptoms persist for more than 7 days or clear up and occur within a few days, discontinue use of this product and consult a doctor.

    Do not use

    • on wounds or damaged skin.

    • Do not bandage tightly. • Caution: Discontinue use if excessive irritation of the skin develops.

    Keep out of reach of children.

    • Use only as directed. • Do not use if pregnant or breastfeeding. • If swallowed, get medical help or contact a poison control center right away.

  • Directions:

    SHAKE WELL BEFORE USE Adults and children 12 years of age and older: Using the roll-on applicator, massage a liberal amount of gel directly on the affected area not more than 3-4 times daily. Children under 12 years of age: Ask a doctor.

  • Other Information:

    Store between 10 and 30ºC (50-86ºF) Avoid freezing and excessive heat above 32ºC (90ºF)

  • Inactive Ingredients:

    Acrylates/Beheneth- 25 Methacrylate Copolymer,Caprylyl Glycol, Chondroitin Sulfate, Ethanol SDA 40B, Eucalyptus Oil, Glucosamine Sulfate, Glycerin, Magnesium Chloride, Peppermint Oil, Phenoxyethanol, Propylene Glycol, Triethanolamine, Water

  • Questions or Comments?

    Call Toll Free: 954-747-3300 Monday through Friday 8:30 AM to 5:00 PM EST. Visit us: www.RelieveAndRelax.com email us: info@RelieveAndRelax.com Or Write us: MAC Innovations, LLC Attn: Quality Assurance Dept. 2301 SW 145th Ave. Miramar, FL USA 33027






  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    RELIEVE AND RELAX PAIN RELIEVING 
    camphor (synthetic), menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81790-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)40 mg  in 1 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81790-001-0088.7 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product06/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01706/01/2021
    Labeler - MAC Innovations, LLC (079554472)
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