GREEN GUARD DERMA-CAINE BURN (BENZALKONIUM CHLORIDE, LIDOCAINE HCL) CREAM [UNIFIRST FIRST AID CORPORATION]

GREEN GUARD DERMA-CAINE BURN (BENZALKONIUM CHLORIDE, LIDOCAINE HCL) CREAM [UNIFIRST FIRST AID CORPORATION]
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NDC 47682-319-35, 47682-319-73, 47682-319-99
Set ID 67629392-7e02-321a-e053-2991aa0a0f24
Category HUMAN OTC DRUG LABEL
Packager Unifirst First Aid Corporation
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
  • Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients

    Benzalkonium chloride 0.13%

    Lidocaine HCl 0.5%

  • PURPOSE

    Purpose

    Topical analgesic

  • INDICATIONS & USAGE

    Uses

    First aid to help prevent infection in minor cuts, scrapes and burns.

    For the temporary relief of pain or itching associated with:

    • sunburn
    • minor burns
    • insect bites
    • minor skin irritation
    • cuts
    • scrapes
  • WARNINGS

    Warnings

    For external use only.

    Do not use

    • in the eyes
    • over large areas of the body or on deep puncture wounds, animal bites or serious burns
    • in large quantities, particularly over raw surfaces or blistered areas

    Stop use and ask a doctor if

    • the condition gets worse
    • condition clears up and recurs within a few days
    • condition persists for more than 7 days

    If pregnant or breast feeding, ask a health care professional before use.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    Adults and children 12 years and over:

    • clean the affected area
    • apply a small amount of this product on the area 3 to 4 times daily
    • may be covered with a sterile bandage

    Children under 12 years:

    • consult a doctor
  • OTHER SAFETY INFORMATION

    Other information

    • store in a cool, dry area 59° to 79° F (15° to 25°C)
    • tamper evident sealed packets
    • do not use any opened or torn packets
  • INACTIVE INGREDIENT

    Inactive ingredients

    decolorized aloe vera, emulsifying wax, ethyl alcohol, methylparaben, mineral oil, paraffin, petrolatum, propylparaben, purified water, white petrolatum, white wax

  • QUESTIONS

    Questions or comments? 1-800-869-6970

  • Green Guard Derma-Caine Burn Cream Label

    Green Guard

    Derma-Caine burn cream

    Antiseptic and pain relieving cream for monor cuts, scrapes and burns

    Benzalkonium Chloride 0.13%/Topical Antiseptic

    Lidocaine HCl 0.5%/Topical Analgesic

    0.9 Gram 25 Single Dose Packets

    Reorder #3106

    Distributed by Green Guard®, Str. Louis, Missouri 63045

    Green Guard

  • INGREDIENTS AND APPEARANCE
    GREEN GUARD DERMA-CAINE BURN 
    benzalkonium chloride, lidocaine hcl cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-319
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 g
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    ALCOHOL (UNII: 3K9958V90M)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47682-319-7325 in 1 BOX03/12/2018
    1NDC:47682-319-990.9 g in 1 PACKET; Type 0: Not a Combination Product
    2NDC:47682-319-35144 in 1 BAG03/12/2018
    20.9 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 finalpart34803/12/2018
    Labeler - Unifirst First Aid Corporation (832947092)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prestige Packaging080667761repack(47682-319)

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