Label: SHENG CHUN HERBAL PAIN RELIEVING- 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 February 20, 2014

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  • Drug Facts Active Ingredients

    Menthol 5%

    Methyl Salicylate 1%

  • Purpose

    External analgesic

  • Keep out of reach of children

    Keep out of reach of children to avoid accidental poisoning.

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • Uses

    For the temporary relief of minor aches and pains of muscles and joints due to:

    • arthritis
    • strains
    • bruises
    • sprains
    • simple backaches
  • Warnings

    For external use only

    Do not use otherwise than as directed.

  • Do not use

    • on wounds
    • irritated or damaged skin
    • sensitive skin
    • with a heating pad
    • if pregnant
    • with, or as the same time as other external analgesic products
    • if allergic to aspirin or salicylates
    • if allergic to any ingredients of this product
  • When using this product

    • avoid contact with the eyes
    • do not bandage tightly
    • do not apply to wounds or damaged skin
    • do not use more than 3 plasters a day
    • do not use 1 hour before or after bathing
  • Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days
    • symptoms clear up and occur again within a few days
    • excessive irritation of the skin develops
    • rashes, itching or redness are present
    • side effects occur. You may call: 1-800-617-2021
  • If pregnant,

    ask a health professional before use.

  • Directions

    • Adults and children 12 years of age and older: clean and dry affected area. Remove patch from the protective layer, apply to the affected area, rub the area with your hand to secure the patch.
    • Patch will remain effective for 8 hours.
    • Avoid using the same patch on the same area for more than 2 days.
    • Do not apply to area with excessive hair. Adhesive patch may hurt skin upon removal.
    • Wet patch with warm water before removing from skin.
    • Children under 12 years of age: Do not use or consult a doctor.
  • Other Information

    • Store unused patch in the pouch
    • Store at room temperature, 20 to 25° C (68  to 77° F)
  • Inactive Ingredients

    Chinese Clematidis Root and Rhizome, Yellow wax, Momordica cochinchinensis seeds, Castor Seeds, Myrrh, Frankincense, Sesame Oil, Resin, FD and C Blue No. 2, FD and C Yellow No. 4, Zinc Oxide

  • Questions or comments

    Call 1-800-617-2021

  • Product Label

    GMP

    "SHENG CHUN" HERBAL PATCH
    Pain Relieving Patch

    backache  arthritis  strains  bruises  sprains

    FOR EXTERNAL USE ONLY  

    Contains 3(11X15cm 4.3inchX5.9inch)Patches

    "GREEN PATCH"

    For the temporary relief of muscles and joints associated with arthritis

    Manufactured by:
    SHENG CHUN TANG PHARMACEUTICAL INDUSTRIAL CO., LTD. TAIWAN

    Distributed by:
    Albert Max
    13859 Redwood Ave. Chino, CA 91710 USA

    Made in Taiwan

    AM ShengChun103 Label


  • INGREDIENTS AND APPEARANCE
    SHENG CHUN HERBAL  PAIN RELIEVING
    menthol, methyl salicylate patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67473-103
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.05 g  in 1 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE0.01 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CLEMATIS CHINENSIS ROOT (UNII: 8Z18N528CU)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    MOMORDICA COCHINCHINENSIS SEED (UNII: 2T87O1UPVD)  
    RICINUS COMMUNIS SEED (UNII: 7EK4SFN1TX)  
    MYRRH (UNII: JC71GJ1F3L)  
    FRANKINCENSE (UNII: R9XLF1R1WM)  
    SESAME OIL (UNII: QX10HYY4QV)  
    PINUS MASSONIANA RESIN (UNII: 64S07U83T7)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67473-103-013 in 1 BOX
    14 g in 1 PATCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/01/2005
    Labeler - Sheng Chun Tang Pharmaceutical Industrial Co., Ltd (656347754)
    Registrant - Albert Max, Inc. (149445798)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sheng Chun Tang Pharmaceutical Industrial Co., Ltd656347754manufacture(67473-103)
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