Label: PAIN RELIEF CREAM- camphor 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 March 24, 2016

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  • ACTIVE INGREDIENT

    Camphor 1%

  • PURPOSE

    External Analgesic

    Topical Analgesic

    Pain relieving cream

  • INDICATIONS & USAGE

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

    -simple backache

    -arthritis

    -strains

    -bruises

    -spains

  • KEEP OUT OF REACH OF CHILDREN

    Children under 2 years of age: consult a doctor.

  • WARNINGS

    For extenal use only

    Do not use:

    -on wounds

    -on irritated or damaged skin

    -otherwise than as directed

    When using this product:

    -avoid contact with the eyes or mucous membranes

    -do not bandage tightly

  • DOSAGE & ADMINISTRATION

    -adults and children 3 years of age and older: apply 3 or 4 drops of medicate oil to the affecte area 1 to 2 times daily. After applying the product, a warm pad may be placed on the affected area for 10 minutes and ten massaged as shown in the illustrations.

    -Children under 3 years of age, consult your physician

    -refer to the above warning; otherwise than as directed may be dangerous

  • 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

  • Pain Relief Cream

    Pain Relief Cream

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF CREAM 
    camphor cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70576-001
    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
    MINERAL OIL (UNII: T5L8T28FGP)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ILEX PUBESCENS ROOT (UNII: V5V22LFX73)  
    PHERETIMA ASPERGILLUM (UNII: 1842H27PGA)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ARALIA CHINENSIS WHOLE (UNII: 4048809221)  
    OLDENLANDIA DIFFUSA (UNII: 291PPU5K9I)  
    PINUS MASSONIANA LEAF (UNII: OFD5T4515T)  
    AMPELOPSIS GLANDULOSA VAR. BREVIPEDUNCULATA FRUIT (UNII: Y6SZ1HB5NG)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIMETHYL SULFOXIDE (UNII: YOW8V9698H)  
    LANOLIN (UNII: 7EV65EAW6H)  
    MACLURA COCHINCHINENSIS ROOT (UNII: 3WTU9E1VPU)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)  
    DRYNARIA FORTUNEI ROOT (UNII: 731W842X8Q)  
    ADINA RUBELLA ROOT (UNII: UUJ7O41XPT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70576-001-0130 g in 1 TUBE; Type 0: Not a Combination Product03/30/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/30/2016
    Labeler - Health Town Inc (140637161)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Apeloa Kangyu Natural Pharmaceutical Co., Ltd420823163manufacture(70576-001)