WOUND AND BURN CARE REFILL PACK (BENZALKONIUM CHLORIDE, LIDOCAINE HCL) KIT [CVS]

WOUND AND BURN CARE REFILL PACK (BENZALKONIUM CHLORIDE, LIDOCAINE HCL) KIT [CVS]
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NDC 52124-0040-1, 69842-401-00
Set ID 44b9b575-b998-60a8-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager CVS
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART333A
  • Active Ingredients

    Benzalkonium Chloride 0.13%
    Lidocaine HCL 0.5%

  • Purpose

    First aid antiseptic, external analgesic

  • Uses

    First aid to help prevent infection and for the temporary relief of pain and itching associated with:

    Minor Cuts

    Scrapes

    Burns

  • Warnings

    For external use only

  • Do Not Use

    Do not use: In eyes, in large quantities, over raw blistered areas, or on deep puncture wounds, animal bites or serious burns, for more than one week

    Do not use:
    in the eyes or apply over large areas of the body.
    longer than 1 week unless directed by a doctor.
    in large quantities, particularly over raw surfaces or blistered areas.

    Ask a doctor before use if you have deep puncture wounds, animal bites or serious burns.

    When using this product, avoid contact with the eyes.

  • Stop Use

    Stop use and ask a doctor if
    condition worsens
    symptoms persist for more than 7 days
    condition clears up and occurs again within a few days

  • Keep Out of Reach of Children

    Keep out of reach of Children.

    If ingested, contact a Poison Control Center right away.

  • Directions

    Adults and children 2 years of age and older

    clean affected area.

    apply a small amount of this product on the area 1 to 3 times daily.

    may be covered with a sterile bandage

    children under 2 years of age: consult a doctor

  • Storage and Handling

    Other Information:

    Store at room temperature (do not freeze).

    Taper evident sealed packets.

    Do not use packet if opened or torn.

  • Inactive Ingredients

    Peregal-O

    Glycerin monostearate

    Glycerol

    Purified Water.

  • PRINCIPAL DISPLAY PANEL

    Genuine First Aid Burn Cream

    Antiseptic Pain Relief With Aloe

    Net Wt 0.9g (1/32 oz)

    Manufactured in CHINA for

    Genuine First Aid

    GFA Production Xiamen Co., Ltd
    No. 20 Huli Industrial Park, Meixi Road, Tong'an, Xiamen, Fujian, China 361100
    Tel: 86-592-7269515 Fax: 86-592-7269528 Http: //www.gfaproduction.com

    Burn CreamWound and Burn Care

  • INGREDIENTS AND APPEARANCE
    WOUND AND BURN CARE REFILL PACK 
    benzalkonium chloride, lidocaine hcl kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-401
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-401-001 in 1 BAG; Type 0: Not a Combination Product12/01/2016
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 12 PACKET 2 g  in .9 
    Part 1 of 1
    GENUINE FIRST AID BURN ANTISEPTIC PAIN RELIEF WITH ALOE 
    benzalkonium chloride, lidocaine cream
    Product Information
    Item Code (Source)NDC:52124-0040
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52124-0040-10.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/28/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333A12/01/2016
    Labeler - CVS (062312574)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tender Corporation064437304manufacture(69842-401)

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