Label: PAIN RELIEF CREAM solution

  • NDC Code(s): 78149-205-01
  • Packager: QINGDAO HAINUO BIOLOGICAL ENGINEERING CO., LTD.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated December 13, 2023

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  • Active Ingredient

    Menthol 2%

  • ARNICA MONTANA FLOWER extract，ANGELICA SINENSIS ROOT extract，papaya extract ，Myrrh extract，Heracleum hemsleyanum Diels extract，HOMALOMENA OCCULTA ROOT extract，Boswellia carterii Birdw extract，GLYCERIN，Caprylic capric triglycerride，Laurocapram，Squalane，Water

  • Purpose

    Topical analgesic

  • Use

    temporarily relieves minor pain associated with:

    • arthritis
    • simple backache
    • muscle strains
    • sprains
    • bruises
  • Warnings

    For external use only

    Allergy alert:If prone to allergic reaction from aspirin or salicylates,consult a doctor before use.

  • Do not use

    • Do not bandage tightly or aooly local heat (such as heating pads) to the aera of use.
    • Avoid contact with eyes or mucous membranes.
    • Do not apply to wounds or damaged broken or irritated skin.
    • Do not use at the same time as other topical analgesics.
  • WHEN USING

    Use only as directed.Read and follow all directions and warmings on this label.

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

  • STOP USE

    Stop use and ask a doctor if

    • Condition worsens
    • Symptoms persist for more than 7 days or clear up and occur again within a few days.
    • Redness is present or irritation develops.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed,get medical help or contact a Poison Contriol Center right away.

  • Directions

    • For Use By Adults Only
    • Apply generously to affected area.
    • Massage into painful area until thoroughly absorbed into skin
    • Repeat as necessary.Repeat up 4 times a day.
  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF CREAM 
    pain relief cream solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78149-205
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    ANGELICA SINENSIS ROOT (UNII: B66F4574UG)  
    PAPAYA (UNII: KU94FIY6JB)  
    MYRRH (UNII: JC71GJ1F3L)  
    HERACLEUM HEMSLEYANUM WHOLE (UNII: G3X356J02F)  
    HOMALOMENA OCCULTA ROOT (UNII: PE3TAO734B)  
    BOSWELLIA SACRA WHOLE (UNII: 8O600AZL0W)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    LAUROCAPRAM (UNII: 1F3X9DRV9X)  
    SQUALANE (UNII: GW89575KF9)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78149-205-011 in 1 PACKAGE09/06/2022
    1100 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/06/2022
    Labeler - QINGDAO HAINUO BIOLOGICAL ENGINEERING CO., LTD. (529667276)
    Establishment
    NameAddressID/FEIBusiness Operations
    QINGDAO HAINUO BIOLOGICAL ENGINEERING CO., LTD.529667276manufacture(78149-205)
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