Drug Facts - For use by licensed professionals only

Blue Gel Anesthetic by

Drug Labeling and Warnings

Blue Gel Anesthetic by is a Otc medication manufactured, distributed, or labeled by Dermal Source, Inc., KIRKMAN GROUP, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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.

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Drug Facts - For use by licensed professionals only.


Active Ingredient (in each cc)Purpose
Lidocaine HCl 5%Topical Anesthetic
Tetracaine HCl 1%Topical Anesthetic
Epinephrine 0.1%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, 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, 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 Product04/01/202106/07/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34604/01/202106/07/2022
Labeler - Dermal Source, Inc. (183535629)
Establishment
NameAddressID/FEIBusiness Operations
KIRKMAN GROUP, INC.078525382manufacture(80069-008)

Revised: 6/2022
 

Trademark Results [Blue Gel Anesthetic]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BLUE GEL ANESTHETIC
BLUE GEL ANESTHETIC
78357176 2946976 Live/Registered
Haake, Mary Jane
2004-01-25

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