Label: SHU JIN HUO LUO PAIN RELIEVING- camphor, menthol, methyl salicylate oil

  • 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 April 1, 2021

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  • ACTIVE INGREDIENT

    Active ingredients
    Camphor 10%
    Menthol 16%
    Methyl salicylate 50%

  • PURPOSE

    Purpose
    External analgesic
    External analgesic
    External analgesic

  • INDICATIONS & USAGE

    Uses
    For the temporary relief of minor aches and pains of muscles and joints due to:
    ■ simple backache
    ■ arthritis
    ■ strains
    ■ bruises
    ■ sprains

  • WARNINGS

    Warnings
    For external use only

  • DO NOT USE

    Do not use
    ■ on wounds
    ■ on irritated or damaged skin

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you have
    ■ any concerns about using this product

  • WHEN USING

    When using this product
    ■ do not use otherwise than as directed
    
■ avoid contact with the eyes or mucous membranes

    ■ do not bandage tightly
    
■ do not apply heat to the area in the form of heating pads, hot water bottles, or lamps (doing so increases the risk of serious burns)

  • STOP USE

    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
    
■ nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs

    ■ you feel actual pain or experience blistering or burning after application (it is normal to feel a warming or cooling sensation)
    
■ when using for pain of arthritis:
       ■ pain persists for more than 10 days
       ■ redness is present
       ■ in conditions affecting children under 12 years of age

  • ADVERSE REACTIONS

    Report any unexpected side effects from the use of this product to the FDA MedWatch Program

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children to avoid accidental poisoning. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions
    ■ adults and children 3 years of age and older: apply several drops and rub Into the affected area not more than 3 to 4 times daily
    
■ children under 3 years of age: consult your physician

  • STORAGE AND HANDLING

    Other information
    ■ keep container tightly closed

    ■ store protected from light at 15 to 30 C (59 to 86 F)

  • INACTIVE INGREDIENT

    Inactive ingredients
    Angelica biserrata root, angelica sinensis root, arisaema erubescens root, chaenomeles lagenaria fruit, cinnamomum cassia twig, clematis chinensis root, cyathula officinalis root, dragon’s blood, eleutherococcus nodiflorus root bark, illicium difengpi bark, lavender oil, light mineral oil, ligusticum sinense subsp. chuanxiong root, narcissus jonquilla flower oil, notopterygium franchetii root, and sigesbeckia orientalis flowering top.

  • QUESTIONS

    Questions or comments? (888) 221-3496 M-F 9 am to 5 pm
    ■ you may also report serious side effects to this phone number

  • PRINCIPAL DISPLAY PANEL

    SHU JIN HUO LUO PAIN RELIEVING OIL

    NDC 55614-670-01

    EXTERNAL ANALGESIC

    1.69 FL OZ (50 ML)
    IMAGE OF BOX

  • INGREDIENTS AND APPEARANCE
    SHU JIN HUO LUO PAIN RELIEVING 
    camphor, menthol, methyl salicylate oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55614-670
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)10 g  in 100 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL16 g  in 100 mL
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE50 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANGELICA BISERRATA ROOT (UNII: OJ90180B22)  
    ANGELICA SINENSIS ROOT (UNII: B66F4574UG)  
    ARISAEMA ERUBESCENS ROOT (UNII: 3E8P1PU8SY)  
    CHAENOMELES LAGENARIA FRUIT (UNII: XBC17A15MU)  
    CINNAMOMUM CASSIA TWIG (UNII: 4UD6VQR2UP)  
    CLEMATIS CHINENSIS ROOT (UNII: 8Z18N528CU)  
    CYATHULA OFFICINALIS ROOT (UNII: BRM37UP34O)  
    DRAGON'S BLOOD (UNII: M3YJ2C28IC)  
    ELEUTHEROCOCCUS NODIFLORUS ROOT BARK (UNII: W7PRK433YB)  
    ILLICIUM DIFENGPI BARK (UNII: JRF2FQL2SB)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    LIGUSTICUM SINENSE SUBSP. CHUANXIONG ROOT (UNII: RR83T99U97)  
    NARCISSUS JONQUILLA FLOWER OIL (UNII: QJD826L75Z)  
    NOTOPTERYGIUM FRANCHETII ROOT (UNII: KRT28P6ITK)  
    SIGESBECKIA ORIENTALIS FLOWERING TOP (UNII: 6UL878YAR7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55614-670-011 in 1 BOX03/23/2021
    150 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/23/2021
    Labeler - MADISON ONE ACME INC (096196758)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Dingtai Pharmaceutical Co., Ltd420598724manufacture(55614-670)
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