Label: RITE AID ULTRA STRENGTH MUSCLE RUB- methyl salicylate 30.0%, camphor 4.0%, menthol 10.0% cream

  • 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 March 27, 2023

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  • Active Ingredient

    Camphor 4%

    Menthol 10%

    Methyl salicylate 30%

  • SPL UNCLASSIFIED SECTION

  • Purpose

    Topical Analgesic

    Topical Analgesic

    Topical Analgesic

  • Directions

    temporarily relieves the minor aches and pains of muscles and joints associated with:

    • simple backache
    • arthritis
    • strains
    • bruises
    • sprains
  • Warnings

    For external use only.

  • Do not Use

    • on wounds or damaged skin
    • with a heating pad
    • on a child under 12 years of age with arthritis-like conditions
  • Ask Doctor

    Ask a doctor before use if you have redness over affected area

  • When Using Section

    • use only as directed
    • avoid contact with eyes or mucous membranes
    • do not bandage tightly
  • Stop use and ask a doctor if

    • condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days
  • Keep out of reach of children

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

  • 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 physician
  • Other Information

    • store at 20° to 25°C (68° to 77°F)
    • do not use if tube seal under cap is broken
  • Inactive Ingredients

    carbomer homopolymer type C, cetostearyl alcohol, cetyl alcohol, glycerine monostearate, peg-100 stearate, Phenoxyethanol, polysorbate 60, sodium benzoate, stearic acid, trolamine, water

  • Questions

    www.riteaid.com

  • Rite Aid Ultra Strength Muscle Rub

    label

  • INGREDIENTS AND APPEARANCE
    RITE AID ULTRA STRENGTH MUSCLE RUB 
    methyl salicylate 30.0%, camphor 4.0%, menthol 10.0% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-9993
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM100 mg  in 1 g
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)40 mg  in 1 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE300 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    WATER (UNII: 059QF0KO0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYOXYL 100 STEARATE (UNII: YD01N1999R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-9993-11 in 1 CARTON03/01/2023
    1113 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/01/2023
    Labeler - Rite Aid Corporation (014578892)
    Establishment
    NameAddressID/FEIBusiness Operations
    Anicare Pharmaceuticals Pvt. Ltd.916837425manufacture(11822-9993)
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