Label: PAIN RELIEF CREAM cream

  • 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 5, 2016

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  • 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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