Label: ATOPALM MUSCLE AND JOINT- menthol gel

  • 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 August 15, 2012

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredients

    Menthol 2.5%

  • PURPOSE

    Purpose

    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 this product

    • avoid contact with 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
    • 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. If swallowed, get medical help or contact a Poison Control Center immediately.

  • DOSAGE & ADMINISTRATION

    Directions

    adults and children 12 years of age or older
    apply to affected area not more that 3 to 4 times daily

    children under 12 years of age
    ask a doctor

  • STORAGE AND HANDLING

    Other Information

    • store at 68 - 77 degree Fahrenheit (20 - 25 degrees Celsius)
    • see end of carton or tube crimp for lot number and expiration date
  • INACTIVE INGREDIENT

    Inactive Ingredients

    WATER, GLYCERIN, ISOPROPYL ALCOHOL, STEARIC ACID, CARBOMER, CAMPHOR, MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ARACHAMIDE MEA, CHOLESTEROL, METHYLPARABEN, POLYSORBATE 60, TRIETHANOLAMINE

  • QUESTIONS

    Questions? Call 1-855-ATOPALM

  • SPL UNCLASSIFIED SECTION


    Distributed by: NeoPharm Co., 1 Oyster Bay Drive, Rumson, NJ 07760

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    Pain Relieving Gel                 VANISHING SCENT

    Deep pain relief for minor arthritis pain, sore, aching, strained muscles and simple backache.
    Helps target pain at the source. Vanishing scent makes product ideal for daytime use.

    Vanishing Scent

    ATOPALM (TM)

    MUSCLE AND JOINT GEL

    Menthol 2.5%

    Pain Relief in moisturizing Gel based on US Patented MLE Technology

    Net Wt. 4 oz/113 g

    muscle and joint gel 1
    muscle and joint gel 2
  • INGREDIENTS AND APPEARANCE
    ATOPALM MUSCLE AND JOINT 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51141-0240
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ARACHAMIDE MEA (UNII: 1211AIM8G7)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51141-0240-41 in 1 CARTON
    1113 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/14/2012
    Labeler - NeoPharm Co., Ltd. (965502912)
    Establishment
    NameAddressID/FEIBusiness Operations
    NeoPharm Co., Ltd.631101883manufacture(51141-0240)
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