Label: BAROX S 60G (camphor- synthetic, methyl salicylate, menthol gel

  • 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 September 14, 2018

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  • ACTIVE INGREDIENT

    Active ingredients: L-menthol 0.8%, DL-Camphor 5.9%, Methyl Salicylate 4.6%

  • INACTIVE INGREDIENT

    Inactive Ingredients: Purified Water, Ethanol, Avocado Oil, CetylPalmitate, Polysorbate 80, Cetanol, Dimethyl Sulfone, Carbomer940, Aminomethyl Propanol, Methyl Parahydroxybenzoate, Chitosan, Emu oil, CI 42090

  • PURPOSE

    Purpose: Topical Analgesic

  • WARNINGS

    Warnings:
    For external use only.  Avoid contact with eyes. Keep this and all drugs out of the reach of children.

  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all drugs out of the reach of children.

  • Uses

    Uses:
    Barox S is an anti-inflammatory pain relieving and topical analgesic ointment that is intended to relieve muscle and joint pain associated with arthritis, rheumatalgia, backaches, knee pain, shoulder pain.

  • Direction

    Direction:
    Use only as directed. Adults and Children 12 Years of Age and Older: Apply to affected area not more than 3 to 4 times daily.

  • QUESTIONS

    Questions
    www.barox.co.kr

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    BAROX S 60G 
    camphor (synthetic), methyl salicylate, menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55692-210
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)3.54 g  in 60 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE2.76 g  in 60 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.48 g  in 60 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55692-210-021 in 1 CARTON08/01/2018
    1NDC:55692-210-0160 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/01/2018
    Labeler - Barox Co., Ltd. (688380051)
    Registrant - Barox Co., Ltd. (688380051)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tai Guk Pharm. Co., Ltd_buyeo689060246manufacture(55692-210)
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