Label: AFTER BURN- lidocaine hydrochloride gel

  • NDC Code(s): 44224-5120-0, 44224-5120-1, 44224-5120-2
  • Packager: Tender Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 February 21, 2017

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

  • Active Ingredient

    Lidocaine Hydrochloride 2.50%

  • Purpose

    Topical Analgesic

  • Uses

    For the temporary relief of pain due to minor burns, sunburn, minor cuts, screapes or minor skin irritations

  • Warnings

    For external use only.

    When using this product

    • avoid contact with eyes
    • do not used in large quantities, particularly over raw surfaces or blistered areas
    • do not use longer than 1 week unless directed by a doctor
    • in case of deep puncture wounds, animal bites or serious burns, consult a doctor

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days or clear up and occure again within a few days

    Keep out of reach of children.

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

    If in eyes, flush with water for 15 minutes and call a doctor.

  • Directions

    Clean affected area

    Adults and Children 2 years and older apply small amount to affected area not more than 3 times daily

    Children under 2 years consult a doctor.

  • Inactive Ingredients

    Aloe Vera gel, benzalkonium chloride, carbomer 980, glycerol USP, herbal fragrance, menthol, polysorbate 20, propylene glycol, purified water, and sodium hydroxide (50%)

  • After Burn

    After Burn

    Serious Treatment for Burns

    Cools Burns Fast!

    Advanced Pain Relief with Lidocaine HCl 2.5%

    Clear Soothing Aloe Gel

    Be Ready for

    • Sunburns
    • Scalds
    • Stove Burns
    • and other burns

    AfterBurnRelief.com

    This soothing, clear gel provides immediate pain relief from kitchen burns, sunburns or any other burns, scrapes and cuts. After Burn contains Lidocaine to relieve fain instantly and Aloe to soothe and moisturize skin.

    From the makers of After Bite.

    Tender Corporation Littleton NH 03561

    After Burn

  • INGREDIENTS AND APPEARANCE
    AFTER BURN 
    lidocaine hydrochloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44224-5120
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS25 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MENTHOL (UNII: L7T10EIP3A)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44224-5120-01 in 1 BOX11/01/2016
    159 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:44224-5120-11.8 mL in 1 PACKET; Type 0: Not a Combination Product04/12/2011
    3NDC:44224-5120-2118 mL in 1 TUBE; Type 0: Not a Combination Product04/12/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/12/2011
    Labeler - Tender Corporation (064437304)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tender Corporation064437304manufacture(44224-5120)