Label: WOUND AND BURN CARE REFILL PACK- benzalkonium chloride, lidocaine hcl kit

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 December 28, 2016

If you are a consumer or patient please visit this version.

  • 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)