Label: SINCERE PAIN RELIEF- menthol, methyl salicylate patch

  • 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 October 13, 2016

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  • ACTIVE INGREDIENTS

    Menthol  2.0%

    Methyl Salicylate  2.0%

  • Purpose

    Menthol                    Topical Analgesic
    Methyl Salicylate       Topical Analgesic

  • Uses

    For temporary relief of minor aches and pains of muscles and joints associated with:

    Simple backache
    Arthritis
    Sprains
    Strains
    Bruises

  • Warnings

    For external use only.

  • Do not Use

    On wounds or damaged skin.

    With Other external analgesic products at the same time.

    If you are allergic to any ingredients of this product.

    Otherwise than as directed.

    Avoid contact with the eyes, mucous membranes or rashes.

  • KEEP OUT OF REACH OF CHILDREN

    Keep Out of Reach of Children.

  • Directions

    Adults and children 12 years of age and over:
    1. Clean and dry the affected areas.
    2. Peel off the protective transparent film, paste the gel surface to the affected area.
    3. Remove patch from the skin after at most 12 hours' application. The patch works by cold compression. You may feel cold when using.

    Children under 12 years of age:
    Consult a doctor.

  • STORAGE AND HANDLING

    Avoid storing product in direct sunlight.
    Keep it under seal in cool and dry place.

  • Inactive Ingredients

    Sodium Polyacrylate (8000 MW), Glycerin, Polysorbate 80, Tartaric Acid, Water

  • SPL UNCLASSIFIED SECTION

    Manufactured by Jiangsu Sincere Pharmaceutical Co.; Ltd.

    Building No.8, Boshi Innovation Park NO.101, Nanhai Road, Binhai Industrial Park, Qidong, Jiangsu, China

    Phone Number: 86-21-63532920

    Made in China

  • Drug Facts

    image description

  • INGREDIENTS AND APPEARANCE
    SINCERE PAIN RELIEF 
    menthol, methyl salicylate patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70836-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2 g  in 100 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TARTARIC ACID (UNII: W4888I119H)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70836-001-015 in 1 BOX05/01/2013
    112 g in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/01/2013
    Labeler - Jiangsu Jiangsu Sincere Pharmaceutical Co., Ltd (548270294)
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