ULTRA STRENGTH PAIN RELIEF (CAMPHOR 4%, MENTHOL 10%, METHYL SALICYLATE 30%) SPRAY [CAR ONE]

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ULTRA STRENGTH PAIN RELIEF (CAMPHOR 4%, MENTHOL 10%, METHYL SALICYLATE 30%) SPRAY [CAR ONE]
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NDC 41520-317-00
Set ID 9509c8ee-bb4b-4b81-b21c-1671ce48f135
Category HUMAN OTC DRUG LABEL
Packager Car One
Generic Name
Product Class
Product Number
Application Number PART348
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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:41520-317
    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 mL
    Menthol (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) Menthol10 g  in 100 mL
    Methyl Salicylate (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) Methyl Salicylate30 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41520-317-00118 mL in 1 CAN; Type 0: Not a Combination Product08/26/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/26/2014
    Labeler - Car One (809183973)
    Registrant - Product Quest Mfg (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg927768135manufacture(41520-317) , label(41520-317)
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