REMATEX (REMATEX PAIN RELIEVINGCREAM) CREAM [HOME AIDE DIAGNOSTICS, INC.]

REMATEX (REMATEX PAIN RELIEVINGCREAM) CREAM [HOME AIDE DIAGNOSTICS, INC.]
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NDC 69379-041-01
Set ID 19c1dbe5-db74-3e91-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Home Aide Diagnostics, Inc.
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
  • 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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