PAIN RELIEF CREAM CREAM [ZHEJIANG APELOA KANGYU PHARMACEUTICAL CO., LTD.]

PAIN RELIEF CREAM CREAM [ZHEJIANG APELOA KANGYU PHARMACEUTICAL CO., LTD.]
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NDC 66653-100-01
Set ID 2fbfc4ac-75a5-6e28-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.
Generic Name
Product Class
Product Number
Application Number PART348
  • PURPOSE

    -External Analgesic

    -Topical Analgesic

    -Pain relieving cream

  • KEEP OUT OF REACH OF CHILDREN

    Children under 2 years of age: consult a doctor

  • INDICATIONS & USAGE

    Temporarily relieves minor aches and pains of muscles and joints associated with:

    -simple backache

    -arthritis

    -strains

    -bruises

    -sprains

  • WARNINGS

    Do Not Use:

    -on wounds

    -on irritated or damaged skin

    -otherwise than as directed

  • DOSAGE & ADMINISTRATION

    Adults and children 3 years of age and older: apply 3 to 4 drops of medicated oil to the affected area 1 to 2 times daily. After appling the product, a warm pad may be placed on the affected area for 10 minutes and then massaged as shown in the illustrations.

  • INACTIVE INGREDIENT

    -Yellow Vaseline

    -Wool Grease

    -Liquid Paraffin

    -Stearic Acid

    -Glycerol

    -Triethanolamine

    -Ethylparaben

    -Dimethyl Sulfoxide

    -Radix Illcis Pubescentis

    -Cortex Araliae

    -Pheretima

    -Herba Hedyotis Chrysotricae

    -Radix Pini Massonianae

    -Sophorae Flavescentis Radix

    -Drynariae Rhizoma

    -Radix Adinae Rubellae

    -Radix Cudraniae Cochinchinensis

    -Root from Itea Oblonga Hand.-Mazz

    -Root from Syzygium Grijsii (Hance) Merr.Et

    -Perry & Root from Ampelopsis Sinica (MIQ) W.T. Wang & Root from Ormosia Henryi Prain & Cuscuta Japonica Choisy

  • ACTIVE INGREDIENT

    Camphor 1%

  • PRINCIPAL DISPLAY PANEL

    Pain Relief Cream

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF CREAM 
    pain relief cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66653-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)  
    MACLURA COCHINCHINENSIS ROOT (UNII: 3WTU9E1VPU)  
    LANOLIN (UNII: 7EV65EAW6H)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    ILEX PUBESCENS ROOT (UNII: V5V22LFX73)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    DIMETHYL SULFOXIDE (UNII: YOW8V9698H)  
    ARALIA CHINENSIS WHOLE (UNII: 4048809221)  
    AMPELOPSIS GLANDULOSA VAR. BREVIPEDUNCULATA FRUIT (UNII: Y6SZ1HB5NG)  
    PHERETIMA ASPERGILLUM (UNII: 1842H27PGA)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    OLDENLANDIA DIFFUSA (UNII: 291PPU5K9I)  
    PINUS MASSONIANA LEAF (UNII: OFD5T4515T)  
    DRYNARIA FORTUNEI ROOT (UNII: 731W842X8Q)  
    ADINA RUBELLA WHOLE (UNII: 1S210XS3BZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66653-100-0130 g in 1 TUBE; Type 0: Not a Combination Product04/05/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/05/2016
    Labeler - Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. (420823163)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.420823163manufacture(66653-100)

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