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

  • 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 March 15, 2013

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  • ACTIVE INGREDIENT

    Menthol 7.6%

    Methyl Salicylate 29.0%

  • INDICATIONS & USAGE

    Uses

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

  • 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.

  • 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.

  • INACTIVE INGREDIENT

    Inactive ingredients

    Paraffin, White Petrolatum.

  • PURPOSE

    Purpose

    Pain relieving gel.


  • 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.

  • PRINCIPAL DISPLAY PANEL

    Preferred Plus Pharmacy Cool 'N Heat Therapy Pain Relief Balm

    Jar image

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF BALMPREFERRED PLUS PH  PREFERRED PLUS PHARMACY
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61715-020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL.076 g  in 100 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE.29 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61715-020-9299.2 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/15/2013
    Labeler - Kinray Inc. (012574513)
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