Label: LBRI STOP THE PAIN SUPER ALOE PAIN RELIEF CREAM- menthol, methyl salicylate cream

  • NDC Code(s): 71238-492-00, 71238-492-01
  • Packager: L'BRI HEALTH AND BEAUTY INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 5, 2023

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  • DRUG FACTS:

  • Active Ingredients

    Menthol 5.00%

    Methyl Salicylate 10.00%

    Purpose

    Topical Analgesic

  • Uses:

    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.

    Do not use

    • on damaged or broken skin.

    When using this product

    • Do not bandage tightly.
    • Avoid Contact with eyes.

    Stop use and ask a doctor if

    rash or irritation develops and lasts. condition worsens, or if symptoms persist for 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.

    If pregnant or breast-feeding,

    ask a health professional before use.

  • Directions:

    • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
    • Children under 2 years of age: consult a doctor.
  • Other Information:

    • Protect the product in this container from excessive heat and direct sun.
  • Inactive ingredients:

    a-Bisabolol, Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Calendula Officinalis Extract, Caprylic/Capric Triglyceride, Capsaicin, Carbomer, Cetearyl Alcohol, Ceteareth-20, Ethylhexylglycerin, Eucalyptus Globulus Oil, Euterpe Oleracea (Acai Berry) Fruit Extract, Glucosamine sulfate, Glycerin, Glyceryl Stearate, Magnesium Sulfate, Malus Domestica (Apple) Fruit Cell Culture Extract, Mentha Piperita (Peppermint) Oil, Methylsulfonylmethane (MSM), PEG-100 Stearate, Phenoxyethanol, Polysorbate-20, Rosmarinus Officinalis (Rosemary) Extract, Stearic Acid, Symphytum Offiinale (Comfrey) Extract, Tocopheryl Acetate (Vitamin E), Triethanolamine, ZIngiber Officinalis (Ginger) Extract.

  • Package Labeling:

    Label

  • Package Labeling:

    Label02

  • INGREDIENTS AND APPEARANCE
    LBRI STOP THE PAIN SUPER ALOE PAIN RELIEF CREAM 
    menthol, methyl salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71238-492
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL50 mg  in 1 mL
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    APPLE (UNII: B423VGH5S9)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    ROSEMARY (UNII: IJ67X351P9)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SYMPHYTUM X UPLANDICUM LEAF (UNII: D05HXK6R3G)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GINGER (UNII: C5529G5JPQ)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CAPSAICIN (UNII: S07O44R1ZM)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    ACAI (UNII: 46AM2VJ0AW)  
    GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71238-492-00118 mL in 1 TUBE; Type 0: Not a Combination Product06/19/2023
    2NDC:71238-492-015 mL in 1 PACKET; Type 0: Not a Combination Product06/19/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01506/19/2023
    Labeler - L'BRI HEALTH AND BEAUTY INC (139751148)
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