Label: ATOPALM DEEP PENETRATING PAIN RELIEVING - menthol, methyl salicylate 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 January 19, 2012

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

  • Active Ingredients

    Menthol 10%
    Methyl Salicylate 15%

    Purpose

    Topical Analgesic

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  • 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

    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.

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  • 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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  • Other Information

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

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

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  • Questions or information call toll free:

    1-855- ATOPALM

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  • 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

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  • INGREDIENTS AND APPEARANCE
    ATOPALM DEEP PENETRATING PAIN RELIEVING 
    menthol, methyl salicylate cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:51141-0235
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 10 g  in 100 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y) METHYL SALICYLATE 15 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51141-0235-4 1 in 1 CARTON
    1 113 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 01/17/2012
    Labeler - NeoPharm Co., Ltd. (965502912)
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