Label: ASTONEA BURN CREAM- lidocaine cream

  • NDC Code(s): 77338-100-01
  • Packager: ASTONEA LABS PRIVATE LIMITED
  • Category: HUMAN OTC DRUG LABEL

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 May 16, 2023

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  • Active Ingredients

    Lidocaine HCL 0.5% Topical Analgesic

    Benzalkonium Chloride 0.13% Topical Antiseptic

  • Purpose

    Topical Analgesic

    Topical Antiseptic

  • Uses

    For temporary relief of pain and itching associated with:

    • Sunburn
    • Minor burns,
    • Insect bites,
    • Minor skin irritation,
    • Cuts
    • Scrapes
  • Warnings

    FOR EXTERNAL USE ONLY

  • Do Not Use

    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

    •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.

  • Directions

    Adults and children 2 years and over:

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

    Children under 2 years

    • consult a doctor
  • Other Information

    •store in a cool, dry area 59°-86°F (15°-30°C) •tamper evident sealed packets do not use any opened or torn packets

  • Inactive ingredients

    Aloe barbadensis leaf juice, Cetearyl alcohol, Disodium EDTA, Ethylhexylglycerin, Glycerin, Glyceryl stearate/PEG-100 stearate, Maltodextrin, Mineral oil, Phenoxyethanol, Propylene glycol, Purified water, Stearic acid, Triethanolamine.

  • Principal Display Panel

    Principal Display and Drug Fact Panel

  • INGREDIENTS AND APPEARANCE
    ASTONEA BURN CREAM 
    lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77338-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS0.5 g  in 100 g
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77338-100-010.9 g in 1 PACKET; Type 0: Not a Combination Product05/16/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/16/2023
    Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)
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