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HARMON Extra Strength Pain Relieving Roll-On (Harmon Stores Inc.)

Available Formats

Dosage Form Package Information Links
GEL 89 mL in 1 BOTTLE, WITH APPLICATOR (63940-150-03) Label Information

Complete HARMON Extra Strength Pain Relieving Roll-On Information

  • HARMON Extra Strength Pain Relieving Roll-On



  • Active Ingredient

                         
    Menthol 3.5%


  • Purpose

    Cooling Pain Relief


  • Uses

    Temporary relief from minor aches and pains of sore muscles and joints associated with

    arthritis  strains sprains


  • Warnings:

    For external use only


  • Ask a doctor before use if you have:

    sensitive skin, are pregnant or breast feeding


  • When Using This Product:

    Avoid contact with eyes or mucous membranes 

    Do not apply to wounds, damaged or irritated skin, or excessive irritation develops 

    Do not bandage or use with heating pad or device, ointments, creams, sprays, liniments

    Wash hands after with cool water


  • Stop Use And Ask A Doctor If:

    Conditions worsens, symptoms persist more than 7 days, or clear up and recur


  • Keep out of reach of children:

    If ingested, get medical help. Contact Poison Control Center immediately.


  • Directions:

    Adults / children 2 years and older: Massage onto affected area up to 4 times daily 

    Children under 2 years of age: Consult Physician


  • Other Information:

    Store in cool dry place, lid closed tightly. Keep away from excessive heat or open flame


  • Inactive Ingredients:

    Water, isopropyl alcohol, herbal extract (IIex paraguariensis), carbomer, triethanolamine, silicon dioxide, methylparaben, glycerine, propylene glycol, FD andC blue #1


  • Dist. by Harmon Stores, Inc.

    Union, NJ 07083 USA

    Harmon Stores, Inc.

    Visit us at: www.facevalues.com

    12015 REV 1

    Harmon Satisfaction

    Guaranteed or

    Your Money Back


  • PRINCIPAL DISPLAY PANEL

    Harmon

    Face Values

    Extra Strength

    Pain Relieving

    cooling menthol therapy

    Penetrating - Long Lasting

    Helps Relieve: Arthritis, Back Pain, Sore Muscles and Joints


  • HARMON Extra Strength Pain Relieving Roll-On

    ExtraStrengthPainRelievingRollOn89ml


  • INGREDIENTS AND APPEARANCE
    HARMON EXTRA STRENGTH PAIN RELIEVING ROLL-ON 
    menthol gel
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:63940-150
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 3.5 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63940-150-03 89 mL in 1 BOTTLE, WITH APPLICATOR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part348 09/05/2012
    Labeler - Harmon Stores Inc. (804085293)
    Establishment
    Name Address ID/FEI Business Operations
    Span Packaging Services LLC 557434805 manufacture(63940-150)