BLUE GEL ANESTHETIC- lidocaine hcl, tetracaine hcl, racepinephrine hcl gel 
Dermal Source, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Drug Facts - For use by licensed professionals only.


Active Ingredients (in each cc)Purpose
Lidocaine HCl 5%Topical Anesthetic
Tetracaine HCl 1%Topical Anesthetic
Racepinephrine HCl 0.01%Vasoconstrictor

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

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 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 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

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

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

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
BLUE GEL ANESTHETIC 
lidocaine hcl, tetracaine hcl, racepinephrine hcl gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80069-013
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
Racepinephrine Hydrochloride (UNII: 336096P2WE) (Racepinephrine - UNII:GR0L9S3J0F) Racepinephrine0.1 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)  
Epinephrine Hydrochloride (UNII: WBB047OO38)  
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:80069-013-0128.3495 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/07/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/07/2022
Labeler - Dermal Source, Inc. (183535629)
Establishment
NameAddressID/FEIBusiness Operations
HTO Nevada, Inc. (dba Kirkman)117115846manufacture(80069-013)

Revised: 6/2022
 
Dermal Source, Inc.