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
  • 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 13, 2017

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredients:

    Methyl Salicylate....30.00%

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

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  • PURPOSE

    Purpose

    Topical Analgesic

    Topical Analgesic

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  • INDICATIONS & USAGE

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

    -simple backache  -arthritis   -strains   -bruises   -sprains

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  • 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

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  • WHEN USING

    When using this product:

    -avoid contact with eyes or mucous membranes

    -do not bandage tightly

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  • 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

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  • 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

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  • 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

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  • 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.

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  • INGREDIENTS AND APPEARANCE
    AMPLIFY RELIEF MM 
    methyl salicylate, menthol cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:69837-019
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 3 g  in 10 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 1 g  in 10 g
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:69837-019-01 1 in 1 CARTON 01/17/2017
    1 NDC:69837-019-02 118 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 01/17/2017
    Labeler - International Brand Management, LLC (079794940)
    Establishment
    Name Address ID/FEI Business Operations
    International Brand Management, LLC 079794940 manufacture(69837-019)
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