Label: ARAMARK STAR BURN GEL- lidocaine gel

  • 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 October 28, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Lidocaine 2.0%

  • Purpose

    Pain reliever.

  • Uses

    Temporary pain relief for minor burns. For

    professional use only.

  • Warnings

    For external use only.

    Keep out of reach of children.

    If ingested, get medical help or contact a Poison Control Center directly.

    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 a doctor if

    • the condition worsens or symptoms persist for more

    than 7 days or clear up and occur again within a few days

  • Directions

    • Adults and children 2 years of age and older:

    apply to affected area not more than 3 to 4 times daily

    • Children under 2 years: do not use, consult a doctor

  • Other Information

    • store at room temperature (do not freeze)

    • do not use any open or torn packets

  • Inactive ingredients

    Water, Menthol, Propylene Glycol,

    Triethanolamine, Carbomer,

    Aloe Barbadensis Leaf Extract

  • Questions od Comments?

    1-800-456-7077

  • Package Labeling

    aramark

    25 ct. of 0.9g packets

    BURN GEL

    For Temporary Pain Relief of Minor Burns

    aramarkuniform.com

    MANUFACTURED FOR:
    Aramark
    Lenexa, KS 66219 886-362-2691

    Please retain carton for drug information.

    5600 Box

    0.9g burnGel packet

    res

  • INGREDIENTS AND APPEARANCE
    ARAMARK STAR BURN GEL 
    lidocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81238-4600
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MENTHOL (UNII: L7T10EIP3A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81238-4600-625 in 1 BOX09/09/2021
    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 finalpart34809/09/2021
    Labeler - Western First Aid Safety DBA Aramark (043861524)
    Registrant - Western First Aid Safety DBA Aramark (043861524)
    Establishment
    NameAddressID/FEIBusiness Operations
    Yuyao Jessie Commodity Co., Ltd.529892305MANUFACTURE(81238-4600)
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