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

BLUE GEL ANESTHETIC 
lidocaine hcl, tetracaine hcl, epinephrine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80069-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Lidocaine Hydrochloride (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987)	Lidocaine Hydrochloride Anhydrous	50 mg  in 1 g
Tetracaine Hydrochloride (UNII: 5NF5D4OPCI) (Tetracaine - UNII:0619F35CGV)	Tetracaine Hydrochloride	10 mg  in 1 g
Epinephrine (UNII: YKH834O4BH) (Epinephrine - UNII:YKH834O4BH)	Epinephrine	1 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80069-008-01	28.3495 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/01/2021	06/07/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	04/01/2021	06/07/2022

Labeler - Dermal Source, Inc. (183535629)

Establishment
Name	Address	ID/FEI	Business Operations
KIRKMAN GROUP, INC.		078525382	manufacture(80069-008)

Revised: 6/2022

Document Id: 100263be-fa6a-47f1-b970-9fe1ac85e595

34390-5

Set id: 93c10d9e-aaa2-402c-a137-630a5f4eac88

Version: 2

Effective Time: 20220607