Label: LIDOCAINE HYDROCHLORIDE gel

  • NDC Code(s): 61010-5000-0, 61010-5000-1, 61010-5000-3, 61010-5000-4, view more
    61010-5000-5, 61010-5000-6
  • Packager: Safetec of America, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 7, 2024

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  • SPL UNCLASSIFIED SECTION

    Pain Relief

    Drug Facts

  • Active Ingredient

    Lidocaine HCl 2.0%

  • Purpose

    Topical pain relief

  • Uses

    Temporary pain relief for minor burns

  • Warnings

    For external use only

    Do not use

    • In large quantities, particularly over raw or blistered areas
    • near eyes, if this happens rinse thoroughly with water

    Stop use and ask doctorif condition worsens or persists for more than 7 days or clears up and occurs again within a few days

    Keep out of reach of children.

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

  • Directions

    • for adults and children 2 years and older: apply to affected area not more than 4 times daily
    • children under 2: do not use, consult a doctor
  • Inactive ingredients

    aloe vera, carbomer, germaben II, propylene glycol, purified water, menthol, triethanolamine, vitamin E acetate

  • PRINCIPAL DISPLAY PANEL – 0.125 oz. packet

    NDC 61010-5000-0

    Safetec

    Burn Gel

    For Temporary
    Pain Relief of
    Minor Burns

    0.125 oz. (3.7 ml)
    Reorder no. 50000

    Manufactured by
    SAFETEC OF AMERICA, Inc.
    Buffalo, NY 14215
    800-456-7077
    www.safetec.com

    PRINCIPAL DISPLAY PANEL – 0.125 oz. packet
  • PRINCIPAL DISPLAY PANEL – 4 oz. bottle

    NDC 61010-5000-1

    Safetec

    First Aid
    Burn Gel

    For Temporary
    Pain Relief of
    Minor Burns

    4 fl. oz. (118 ml)
    Reorder no. 50001

    PRINCIPAL DISPLAY PANEL – 4 oz. bottle
  • Principal Display Panel - Pouch label

    Safetec

    Burn Gel

    0.9 g (1/32 oz.)

    Safetec of America, Inc.

    Buffalo, NY 14215

    800-456-7077

    Principal Display Panel - Pouch label
  • Principal Display Panel - 144 Box label

    NDC 61010-5000-04

    Safetec

    First Aid

    Burn Gel

    For Temporary Pain Relief
    of Minor Burns

    Reorder No. 50007

    To reorder:

    Call: 1-800-456-7077

    Fax: 716-895-2969

    Online: www.safetec.com

    Principal Display Panel - 144 Box label
  • Principal Display Panel - 25 Box label

    NDC 61010-5000-5

    Safetec

    First Aid

    Burn Gel

    For Temporary Pain Relief
    of Minor Burns

    25 Packets

    Each Packet Net. Wt. 0.9gm

    Principal Display Panel - 25 Box label
  • Principal Display Panel – 10 Packet Box Label

    Safetec ®

    First Aid

    Burn Gel

    Quickly soothes pain
    caused by minor burns

    10 Packets

    Each Packet Net. Wt. 0.9g

    Made in USA

    Reorder No. 50028

    Principal Display Panel – 10 Packet Box Label
  • INGREDIENTS AND APPEARANCE
    LIDOCAINE HYDROCHLORIDE 
    lidocaine hydrochloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61010-5000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    WATER (UNII: 059QF0KO0R)  
    MENTHOL (UNII: L7T10EIP3A)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61010-5000-03.3 g in 1 PACKET; Type 0: Not a Combination Product09/19/2012
    2NDC:61010-5000-1121.2 g in 1 BOTTLE; Type 0: Not a Combination Product09/19/2012
    3NDC:61010-5000-30.9 g in 1 POUCH; Type 0: Not a Combination Product09/19/2012
    4NDC:61010-5000-4144 in 1 CARTON09/19/2012
    40.9 g in 1 POUCH; Type 0: Not a Combination Product
    5NDC:61010-5000-525 in 1 CARTON09/19/2012
    50.9 g in 1 POUCH; Type 0: Not a Combination Product
    6NDC:61010-5000-610 in 1 BOX04/01/2020
    60.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01709/19/2012
    Labeler - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262manufacture(61010-5000)
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