Label: FOOT REHAB PAIN RELIEF AND MOISTURIZER MISSION- menthol, methyl salicylate cream

  • NDC Code(s): 76347-120-01
  • Packager: Mission Product Holdings
  • 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 12, 2013

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  • ACTIVE INGREDIENT

    Active Ingredient Purpose

    Menthol 10% Topical Analgesic

    Methyl Salicylate 15 % Topical Analgesic

    Uses:

    Temporarily relieves minor aches and pains of muscles and joints associated with

    - simple backache

    - arthritis

    - strains

    - bruises

    - sprains

    Keep out of the reach of children to avoid accidental ingestion.

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

    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

    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

    Directions

    -Use only as directed

    adults and children 12 years of age or older

    - Apply to affected area not more than 3 to 4 time daily.

    Children under 12 years of age -ask a doctor

    Inactive ingredients: Water, Glycerin, Cetyl aclohol, PEG-15 Glyceryl Stearate,Glyceryl Stearate, Stearic acid, Stearyl Alcohol, Myristoyl/palmitoyloxostearamide/Arachamide MEA, Carbomer 940, Cholesterol, Trolamine, Isopropyl Myristate, Methylparaben, Propylparaben.

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  • PRINCIPAL DISPLAY PANEL

    back

    front

    Mission

    Foor Rehabâ„¢ Pain relief & moisturizer

    fast temporary relief from minor foot pain

    non greasy formula

    10% Menthol

    Dual Action: Pain relief & moisturizing


    Net Wt 3 oz // 85 G

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  • INGREDIENTS AND APPEARANCE
    FOOT REHAB PAIN RELIEF AND MOISTURIZER  MISSION
    menthol, methyl salicylate cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:76347-120
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 8.5 g  in 85 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 12.75 g  in 85 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PEG-15 GLYCERYL STEARATE (UNII: 91245SPD5K)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ARACHAMIDE MEA (UNII: 1211AIM8G7)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    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:76347-120-01 85 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 11/05/2012
    Labeler - Mission Product Holdings (808672120)
    Registrant - Mission Product Holdings (808672120)
    Establishment
    Name Address ID/FEI Business Operations
    Neopharm CO. Ltd 631101883 manufacture(76347-120)
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