Label: SINSINPAS AREXLOTION- l-menthol lotion

  • NDC Code(s): 55264-112-01, 55264-112-02
  • Packager: Sinsin Pharmaceutical Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 5, 2024

If you are a consumer or patient please visit this version.

  • Active Ingredients

    Methyl Salicylate 200.0mg

    L-Menthol 60.0mg

    Tocopherol Acetate 1.0mg

  • Purpose

    Topical Analgesic

  • Uses

    Temporarily relieves minor pain associated with:

    • Arthritis
    • Simple backache
    • Muscle strains
    • Sprains
    • Bruises
    • Cramps
  • Warnings

    For external use only

    allergy alert: If prone to allergic reaction from aspirin or salicylates or allergic to any ingredients in this product, consult a doctor before use.

    When using this product

    • use only as directed
    • avoid contact with eyes and mucous membranes or rashes
    • rare cases of serious burns have been reported with products of this type
    • do not apply to wounds or damaged, broken irritated skin
    • do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of use
    • do not use at the same time as other topical analgesics
    • a transient burning sensation may occur upon application but generally disappears in several days
    • if severe burning sensation occurs, discontinue use immediately
    • do not expose the area treated with product to heat or direct sunlight
    • avoid applying into skin folds

    stop use and ask a 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
    • you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

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

    Keep out of reach of children.

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

  • Keep out of reach of children

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    Adults and children 12 years of age and over:

    • apply a thin layer to affected area
    • massage into painful area until thoroughly absorbed into skin

    repeat as necessary, but no more than 3 to 4 times daily

    • AFTER APPLYING, WASH HANDS WITH SOAP AND WATER

    Children undress 12 years of age: ask a doctor

  • Other Information

    • Avoid storing product in direct sunlight, store at 20-25C (68-77F)
    • Store with lid closed tightly
  • Inactive Ingredients

    Nonylic acid vanillyamide, Carbomer 941, Light liquid paraffin, Polysorbate 60, Sorbital Monostearate. Lanolin oil, Triethanolamine, Fresh yuja flavor, Purified water

  • SINSINPAS AREX LOTION

    SINSINPAS AREX LOTION BOTTLESINSINPAS AREX LOTION BOX

  • INGREDIENTS AND APPEARANCE
    SINSINPAS AREXLOTION 
    l-menthol lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55264-112
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE200 mg
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (ALPHA-TOCOPHEROL - UNII:H4N855PNZ1) ALPHA-TOCOPHEROL ACETATE1 mg
    LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL60 mg
    Inactive Ingredients
    Ingredient NameStrength
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    LANOLIN OIL (UNII: OVV5IIJ58F)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CITRUS JUNOS FRUIT (UNII: 53KHW58C1V)  
    CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: F68VH75CJC)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    NONIVAMIDE (UNII: S846B891OR)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55264-112-021 in 1 BOX08/27/2021
    1NDC:55264-112-011 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01708/27/2021
    Labeler - Sinsin Pharmaceutical Co., Ltd. (823149161)
    Registrant - Sinsin Pharmaceutical Co., Ltd. (687867143)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sinsin Pharmaceutical Co., Ltd.687867143manufacture(55264-112)