PAIN RELIEVING BALM (MENTHOL, METHYL SALICYLATE) LIQUID [TOPCO]

PAIN RELIEVING BALM (MENTHOL, METHYL SALICYLATE) LIQUID [TOPCO]
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NDC 36800-738-04
Set ID 031eeb47-9a41-4915-a100-531ca0e88abe
Category HUMAN OTC DRUG LABEL
Packager TopCo
Generic Name
Product Class
Product Number
Application Number PART348
  • ACTIVE INGREDIENT

    Active ingredients                                        Purpose
    Menthol 7.6%.............................................Topical Analgesic
    Methyl Salicylate 29%.................................Topical Analgesic

  • PURPOSE

  • INDICATIONS & USAGE

    Uses

    temporarily relieves minor pain associated with:
    • arthritis • simple backache • muscle strains • bruises
    • muscle sprains • 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 eyes or mucous 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 worsens • redness
    is present • irritation develops • symptoms persist for more
    than 7 days or clear up and occur again within a few days
    If pregnant or breast-feeding, ask a healthcare professional
    before use

  • Keep out of reach of children.

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

  • DOSAGE & ADMINISTRATION

    Directions
    Adults and children over 12 years: • apply generously to
    affected area • massage into painful area until
    thoroughly absorbed into skin • repeat as
    necessary, but not more than 4 times daily.
    Children under 12 years: ask a doctor

  • INACTIVE INGREDIENT

    Inactive ingredients
    Paraffin, White Petrolatum

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEVING BALM 
    menthol, methyl salicylate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-738
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) Menthol7.6 g  in 100 g
    Methyl Salicylate (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) Methyl Salicylate29 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Paraffin (UNII: I9O0E3H2ZE)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-738-0499.2 g in 1 PACKAGE; Type 0: Not a Combination Product11/16/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/16/2011
    Labeler - TopCo (006935977)
    Registrant - Product Quest mfg (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest mfg927768135manufacture(36800-738) , label(36800-738)

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