Label: AMPLIFY RELIEF MM- methyl salicylate, menthol cream

  • NDC Code(s): 69837-019-01, 69837-019-02
  • Packager: International Brand Management, LLC
  • 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 March 13, 2017

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  • ACTIVE INGREDIENT

    Active Ingredients:

    Methyl Salicylate....30.00%

    Menthol.................10.00%

  • PURPOSE

    Purpose

    Topical Analgesic

    Topical Analgesic

  • INDICATIONS & USAGE

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

    -simple backache  -arthritis   -strains   -bruises   -sprains

  • WARNINGS

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

  • WHEN USING

    When using this product:

    -avoid contact with eyes or mucous membranes

    -do not bandage tightly

  • STOP USE

    Stop use and ask a doctor if:

    -condition worsens or symptoms persist for more than 7 days

    -symptoms clear up and occur again within a few days

    -excessive skin irritation occurs

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children to avoid accidental ingestion. If swallowed, get medical help or

    contact a Poison Control Center immediately

  • DOSAGE & ADMINISTRATION

    Directions:

    -use only as directed

    -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: ask a doctor

  • INACTIVE INGREDIENT

    Inactive Ingredients: Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water),

    Arnica Montana Flower Extract, Boswellia Serrata Extract, Calendula Officinalis Extract, Cannabis

    Sativa (Hemp) Seed Oil, Cetearyl Olivate, Cetyl Alcohol, Chondrotin Sulfate, Gluconolactone,

    Glucosamine Sulfate, Glycerin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Oil, Magnesium

    Sulfate, Methylsulfonylmethane (MSM), Sodium Benzoate, Sodium Laurylglucosides

    Hydroxypropylsulfonate, Sorbitan Olivate, Tapioca Starch, Xanthan Gum, Zemea (Corn)

    Propanediol.

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    AMPLIFY RELIEF MM 
    methyl salicylate, menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69837-019
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE3 g  in 10 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 10 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    Cetearyl Olivate (UNII: 58B69Q84JO)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CHONDROITIN SULFATE (SHARK) (UNII: 2ZAJ1K50XH)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    Glucosamine Sulfate (UNII: 1FW7WLR731)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    STARCH, TAPIOCA (UNII: 24SC3U704I)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69837-019-011 in 1 CARTON01/17/2017
    1NDC:69837-019-02118 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 finalpart34801/17/2017
    Labeler - International Brand Management, LLC (079794940)
    Establishment
    NameAddressID/FEIBusiness Operations
    International Brand Management, LLC079794940manufacture(69837-019)