Label: ULTRA STRENGTH PAIN RELIEF- camphor 4%, menthol 10%, methyl salicylate 30% spray

  • 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 June 25, 2018

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  • Active ingredients                             Purpose

    Camphor – 4.00%                                Topical Analgesic
    Menthol – 10.00%                               Topical Analgesic
    Methyl Salicylate – 30.00%                Topical Analgesic

  • PURPOSE

  • Uses

    • temporarily relieves minor pain associated with:
    • arthritis
    • simple backache
    • muscle strains
    • bruises
    • muscle sprains
  • Warnings

    ​For external use only

    Flammable

     • keep away from fire or flame. • avoid long term
    storage above 104˚F. • do not puncture or incinerate. Contents under
    pressure. • do not store at temperatures above 120˚F

    • do not use while smoking or near heat or flame
    • avoid long term storage above 104F
    • do not puncture or incinerate. Contents under pressure
    • do not store at temperature above 120F

    When using this product

    • avoid contact with eyes and mucous membranes
    • do not apply to wounds or damages skin
    • do not bandage tightly or use with a heating pad
    • use only as directed

  • Stop use and ask a doctor if

    • condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days

  • Keep out of reach of the children

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

  • If pregnant or breast-feeding, ask a health professional before use

  • Directions

    • shake well
    • adults and children 2 years of age and older: spray on affected area, not more than 3 to 4 times daily
    • children under 2 years of age: consult a doctor

  • Inactive ingredients

    Alcohol Denat.

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    ULTRA STRENGTH PAIN RELIEF 
    camphor 4%, menthol 10%, methyl salicylate 30% spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64048-5114
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)4 g  in 100 g
    Menthol (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) Menthol10 g  in 100 g
    Methyl Salicylate (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) Methyl Salicylate30 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64048-5114-4113 g in 1 CAN; Type 0: Not a Combination Product02/06/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/06/2014
    Labeler - Product Quest Mfg (927768135)
    Registrant - Product Quest Mfg (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg927768135manufacture(64048-5114) , label(64048-5114)
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