Label: AMP RELIEF PAIN RELIEF CREAM- menthol 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 February 10, 2022

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

  • Drug Facts

  • Active Ingredients

    Menthol 8.00%

    Purpose

    Topical Analgesic

  • Uses:

    • For the temporary relief of minor aches and pains of muscles and joints, associated with backache, arthritis, strains, bruises and sprains
  • Warnings:

    For external use only.

    Do not use 

    • on damaged or broken skin

    When using thsi product 

    • Avoid contact with the eyes.
    • Do not bandage tightly.

    Stop use and ask a doctor if

    • rash or irritation develops and lasts
    • condition worsens 
    • symptoms persist for more than 7 days 
    • clears up and occurs 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-feeing,

    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

    Flammable:

    • Keep away from excessive heat or open flame.
  • Inactive ingredients:

    Acrylates/c10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Ethylhexylglycerin, Eucalyptus Globulus Oil, Glycerin, Isopropyl Myristate, Methyl Salicylate, Paraffinum Liquidum, Phenoxyethanol, Polysorbate-80, SD-Alcohol 40B Triethanolamine, FD&C Blue #1, FD&C Yellow #5

  • Questions?

    1(888) 510-6289

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    AMP RELIEF PAIN RELIEF CREAM 
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82560-273
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL80 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82560-273-00118.29 mL in 1 TUBE; Type 0: Not a Combination Product02/15/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/15/2022
    Labeler - COASTAL FORMULAS LLC (085954368)