Label: REMATEX- rematex pain relievingcream cream

  • NDC Code(s): 69379-041-01
  • Packager: Home Aide Diagnostics, Inc.
  • 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 June 30, 2015

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS


    Lidocain 4% --------------------------------------------------------------------------------------------------------- Topical analgesic
    Menthol 1% --------------------------------------------------------------------------------------------------------- Topical analgesic

  • PURPOSE

    INDICATIONS


    For the temporary relif of minor aches and pains of muscles and joints associated with:

    • Simple Backache
    • Arthritis
    • Strains
    • Sprains
    • Bruises
  • WARNINGS

    WARNINGS


    FOR EXTERNAL USE ONLY.

    • Avoid contact with eyes.
    • If condition worsens, of if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a s physician.
    • Do not apply to wounds or damaged skin
    • Do not bandage tightly
  • DOSAGE & ADMINISTRATION

    DIRECTIONS

    • Clean and dry affected area
    • Remove patch from backing and apply to affected area
    • Use only one patch at a time and maximum of four patches daily
    • Leave patch on affected area for up to 8-hours
    • Do not use patches for longer than 5 consecutive days unless directed by a physician.
    • Store below 25 °C (77 °F). Avoid direct sunlight.
  • KEEP OUT OF REACH OF CHILDREN

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

  • PREGNANCY OR BREAST FEEDING

    If pregnant of breast-feeding, ask a healthcare professional before use

    • This product may cause allergic reaction in some individuals.
  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS

    aliphatic alcohol; stearic acid; vaseline; peregal; Carmellose Sodium; water;

  • INDICATIONS & USAGE

    • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
    • Children under 2 years of age: consult a physician.
  • PRINCIPAL DISPLAY PANEL

    VELTRIX.jpg

  • INGREDIENTS AND APPEARANCE
    REMATEX 
    rematex pain relievingcream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69379-041
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 g
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69379-041-01120 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/01/2015
    Labeler - Home Aide Diagnostics, Inc. (783518983)
    Registrant - Zhejiang Bangli Medical Products Co. Ltd (421295875)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Bangli Medical Products Co. Ltd421295875manufacture(69379-041)
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