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 19eb9717-94aa-2fd5-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

    PURPOSE

    Topical analgesic

  • WARNINGS

    WARNINGS


    FOR EXTERNAL USE ONLY.

    • When using this product use only as directed
    • Do not bandage tightly
    • Do not use with a heating pad
    • Avoid contact with the eyes or mucous membranes
    • Do not apply to wounds or damaged or irritated skin
  • DOSAGE & ADMINISTRATION

    DIRECTIONS

    Adults and children over 12 years

    • Apply generously to affected area
    • Massage into painful area until thoroughly absorbed into skin, repeat as necessary, not more than 3-4 times daily
    • Store at 20°-25°C (68°-77 °F). Avoid direct sunlight.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    f swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

  • PREGNANCY OR BREAST FEEDING

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

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS

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

  • INDICATIONS & USAGE

    INDICATIONS


    For the temporarily relieves minor pain associated with:

    • Simple Backache
    • Arthritis
    • Strains
    • Sprains
    • Bruises
  • STOP USE

    STOP USE AND ASK A DOCTOR IF

    • Condition worsens
    • Symptoms persist for more than 7 days or clear up and occur again within a few days
    • Redness is present
    • Irritation develops
  • 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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