Label: PAIN RELIEF BALMPREFERRED PLUS PH PREFERRED PLUS PHARMACY- menthol and methyl salicylate gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 03/13

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  • ACTIVE INGREDIENT

    Menthol 7.6%

    Methyl Salicylate 29.0%

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  • INDICATIONS & USAGE

    Uses

    Temporarily relieves minor pain associated with:  arthritis, simple backache, muscle strains, bruises, sprains and cramps.

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  • WARNINGS

    Warnings

    For external use only.  Allergy alert:  if prone to allergic reaction from aspirin or salicylates, consult a doctor before use.  When using this product: use only as directed, avoid contact with the eyes or mucus membranes, do not bandage tightly or use with a heating pad, do not apply to wounds or damaged skin. Stop use and ask doctor if:  condition gets worse, symptoms last more than 7 days, or symptoms clear up and occur again in a few days.  If pregnant or breast-feeding:  ask a healthcare professional before use.

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  • DOSAGE & ADMINISTRATION

    Directions

    Adults and children 12 years of age and older:  apply generously to affected area.  Massage into painful are until thoroughly absorbed into skin.  Repeat as necessary, but not more than 4 times daily.  Children under 12 years of age: ask doctor.

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  • INACTIVE INGREDIENT

    Inactive ingredients

    Paraffin, White Petrolatum.

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  • PURPOSE

    Purpose

    Pain relieving gel.


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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

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

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  • PRINCIPAL DISPLAY PANEL

    Preferred Plus Pharmacy Cool 'N Heat Therapy Pain Relief Balm

    Jar image



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  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF BALMPREFERRED PLUS PH  PREFERRED PLUS PHARMACY
    menthol gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:61715-020
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (MENTHOL) MENTHOL .076 g  in 100 g
    METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE .29 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    PARAFFIN  
    PETROLATUM  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:61715-020-92 99.2 g in 1 JAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 03/15/2013
    Labeler - Kinray Inc. (012574513)
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