Label: BLUE GEL ANESTHETIC- lidocaine hcl, tetracaine hcl, epinephrine gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 22, 2021

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

  • ACTIVE INGREDIENT


    Active Ingredient (in each cc)Purpose
    Lidocaine HCl 5%Topical Anesthetic
    Tetracaine HCl 1%Topical Anesthetic
    Epinephrine 0.1%Vasoconstrictor
  • INDICATIONS & USAGE

    Uses: External Use Only. Temporarily relieves pain and swelling due to tattooing, permanent makeup or other pain sensitive procedures.

  • WARNINGS

    Warnings: Avoid contact with eyes.
    Do not swallow.     Keep out of children's reach.
    Do not use if you have

    • A history of severe liver disease or impairment
    • A known allergy or sensitivity to any of the components of this product.

    If sensitivity occurs, consult a doctor if condition worsens or does not improve in seven days, or clears up and occurs again within a few days. Do not use in large quantities, particularly over raw surfaces or blistered areas.

  • DO NOT USE

    Do not use if pregnant or nursing. In case of accidental contact with eyes, rinse immediately with copious amounts of eyewash. Seek care by an eye care physician. If accidentally swallowed, get medical help immediately.

  • WHEN USING

    When using this product 

    • You may notice temporary blanching, skin irritation or sensitivity of the skin where gel is applied
    • You may not have pain - avoid sources of heat or injury
    • You may have delayed swelling after drug is dissipated
  • STOP USE

  • KEEP OUT OF REACH OF CHILDREN

  • DOSAGE & ADMINISTRATION

    Directions:  Sensitivity test advised prior to use.

    Apply sparingly to broken skin and cover with occlusive dressing. Product is ineffective when applied to intact skin. Wait until anesthetic effect occurs (2-5 minutes). Remove product before continuing with your procedure.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Purified Water, Ethoxydiglycol, Propylene Glycol, Hydroxyethylcellulose, Sodium Metabisulfite, Diazolidinyl Urea, Disodium EDTA, Methyl Paraben, Propyl Paraben, Sodium Citrate, Citric Acid, FD&C Yellow 5, and FD&C Blue 1.

  • STORAGE AND HANDLING

    Other information: Store in cool dark place or refrigerate.
    Discard after expiration date.

  • QUESTIONS

    Questions? Contact distributor on product label for further questions.

  • PRINCIPAL DISPLAY PANEL

    NEW & IMPROVED

    BLUE GEL
    ANESTHETIC

    To reduce pain and swelling during pain sensitive procedures

    1 oz.

    Distributed by: DERMAL SOURCE
    Portland, OR 97232

    www.dermalsource.com
    1-866-568-3223

    label
  • INGREDIENTS AND APPEARANCE
    BLUE GEL ANESTHETIC 
    lidocaine hcl, tetracaine hcl, epinephrine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80069-008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Lidocaine Hydrochloride (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987) Lidocaine Hydrochloride Anhydrous50 mg  in 1 g
    Tetracaine Hydrochloride (UNII: 5NF5D4OPCI) (Tetracaine - UNII:0619F35CGV) Tetracaine Hydrochloride10 mg  in 1 g
    Epinephrine (UNII: YKH834O4BH) (Epinephrine - UNII:YKH834O4BH) Epinephrine1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Diethylene Glycol Monoethyl Ether (UNII: A1A1I8X02B)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Hydroxyethyl Cellulose, Unspecified (UNII: T4V6TWG28D)  
    Sodium Metabisulfite (UNII: 4VON5FNS3C)  
    Diazolidinyl Urea (UNII: H5RIZ3MPW4)  
    Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Sodium Citrate, Unspecified Form (UNII: 1Q73Q2JULR)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Fd&C Yellow No. 5 (UNII: I753WB2F1M)  
    Fd&C Blue No. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80069-008-0128.3495 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34604/01/2021
    Labeler - Dermal Source, Inc. (183535629)
    Establishment
    NameAddressID/FEIBusiness Operations
    KIRKMAN GROUP, INC.078525382manufacture(80069-008)