Label: ATOPALM PAIN RELIEVING- menthol 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 August 15, 2012

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Menthol 10%

  • PURPOSE

    Purpose

    Topical Analgesic

  • INDICATIONS & USAGE

    Uses For temporary relief of 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
  • STOP USE

    Stop use and ask a doctor if

    • conditions worsen
    • symptoms persist for more than 7 days
    • symptoms clear up and occur again within a few days
    • excessive skin irritation occurs
    • have redness over the affected area.
  • WHEN USING

    When using this product avoid contact with eyes or mucous membranes, do not bandage tightly.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help immediately or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    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
  • INACTIVE INGREDIENT

    Inactive Ingredients

    WATER, GLYCERIN, CETYL ALCOHOL, POLYSORBATE 60, GLYCERYL STEARATE, STEARIC ACID, DIMETHICONE, ISOPROPYL MYRISTATE, MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ARACHAMIDE MEA, CARBOMER, TRIETHANOLAMINE, CHOLESTEROL, ALOE VERA GEL, METHYLPARABEN, PROPYLPARABEN.

  • STORAGE AND HANDLING

    Other Information

    store at 20 - 25 degrees Celsius (68 - 75 degrees Fahrenheit)

    see carton or flap or tube crimp for  lot number and expiration date

  • QUESTIONS

    Questions or information call toll free: 1-855-ATOPALM

  • SPL UNCLASSIFIED SECTION

    US Patent # US 6221371B1

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

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    Pain Relieving Cream
    Non-Greasy, Non-Staining

    10% Menthol
    Ultra-light Nighttime Scent

    DEEP PENETRATING PAIN RELIEF

    ATOPALM (TM)

    Developed for Nighttime Use

    Goes on smoothly and leaves skin feeling soft and smooth

    Net. Wt. 2 oz/57 g

    Specially Formulated with US Patented MLE Technology


    ATOPALM pain relieving cream outer package

    ATOPALM pain relieving cream tube

  • INGREDIENTS AND APPEARANCE
    ATOPALM PAIN RELIEVING 
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51141-0239
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ARACHAMIDE MEA (UNII: 1211AIM8G7)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51141-0239-21 in 1 CARTON
    157 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(51141-0239)
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