Label: RITE AID HOT AND COLD ROLL ON- menthol 16% liquid

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

Drug Label Information

Updated December 15, 2024

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  • ACTIVE INGREDIENT

    Menthol 16%

  • PURPOSE

    External Analgesic

  • INDICATIONS & USAGE

    For the temporary relief of minor pain associated with arthritis, simple backache, muscle strains, sprains, bruises, and cramps.

  • WARNINGS

    Flammable--keep away from fire or flame.

    For external use only.

    When using this product keep out of eyes, do not apply to wounds or damaged skin, do not bandage tightly.

    Stop use and ask a doctor if condition worsens, symptoms last more than 7 days or clear and occur again within a few days, and redness or irritation develops.

  • KEEP OUT OF REACH OF CHILDREN

    If product is swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Clean affected area before applying product • adults and children 12 years and older, apply to affected area not more
    than 3 to 4 times daily. • Children under 12 years old, ask a doctor

  • INACTIVE INGREDIENT

    Acrylates/C10-30 alkyl acrylate crosspolymer, alcohol denat., glycerin, phenoxyethanol, propylene glycol, water, xanthan gum

  • PRINCIPAL DISPLAY PANEL

    Carton

  • INGREDIENTS AND APPEARANCE
    RITE AID HOT AND COLD ROLL ON 
    menthol 16% liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-1015
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL16 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 132584PQMO)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-1015-11 in 1 CARTON05/22/2023
    171 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01705/22/2023
    Labeler - Rite Aid (014578892)
    Registrant - Derma Care Research Labs, LLC (116817470)
    Establishment
    NameAddressID/FEIBusiness Operations
    Derma Care Research Labs, LLC116817470manufacture(11822-1015)
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