Label: ATOPALM DEEP PENETRATING PAIN RELIEVING- menthol, methyl salicylate cream

  • 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 January 19, 2012

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  • Active Ingredients

    Menthol 10%
    Methyl Salicylate 15%

    Purpose

    Topical Analgesic

  • Uses

    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 wih arthritis like conditions

    Ask a doctor before use if you have

    redness over the affected area

    When using this product

    • avoid contact with the eyes or mucous membranes
    • do not bandage tightly

    Stop use and ask a doctor if

    • condition worsens or symptoms persist for more than 7 days
    • if symptoms clear up and occur again within a few days
    • excessive irritation occurs

    Keep out of reach of children to avoid accidental ingestion.

    If swallowed get medical help or contact a Poison Control Center immediately.

  • 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
  • Other Information

    • store at 68° – 77°F (20° – 25°C)
    • see end of carton or tube crimp for lot number and expiration date
  • Inactive Ingredients

    WATER, GLYCERIN, CETYL ALCOHOL, PEG-15 GLYCERYL STEARATE, STEARIC ACID, GLYCERYL STEARATE, STEARYL ALCOHOL, CARBOMER, TRIETHANOLAMINE, ISOPROPYL MYRISTATE, METHYLPARABEN, PROPYLPARABEN

  • Questions or information call toll free:

    1-855- ATOPALM

  • Product Labeling

    DEEP PENETRATING PAIN RELIEF

    Fast, soothing, temporary relief from minor arthritis, simple backache, muscle and joint pain.

    NON-GREASY CREAM
    ATOPALM
    Pain Relieving Cream

    DEEP PENETRATING PAIN RELIEF

    In a non-greasy cream based on US Patented MLE Technology
    Leaves skin feeling soft, smooth and moisturized.



    4 oz /113 g

    Distributed by: NeoPharm USA, 1 Oyster Bay Drive, Rumson, NJ 07760
    Made in Korea




    Pain Relieving Cream


    Pain Relieving Cream

    Pain Relieving Cream

  • INGREDIENTS AND APPEARANCE
    ATOPALM DEEP PENETRATING PAIN RELIEVING 
    menthol, methyl salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51141-0235
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 g  in 100 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y) METHYL SALICYLATE15 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PEG-15 GLYCERYL STEARATE (UNII: 91245SPD5K)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51141-0235-41 in 1 CARTON
    1113 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/17/2012
    Labeler - NeoPharm Co., Ltd. (965502912)
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