Blue Gel Anesthetic

Manufacturer
Dermal Source, Inc. | HTO Nevada, Inc. (dba Kirkman)
Effective date
2024-05-06
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:03:43

Label at a glance#

ProductBlue Gel Anesthetic
Active ingredientLidocaine Hydrochloride, Tetracaine Hydrochloride, Racepinephrine Hydrochloride
Label structure10 sections

Storage and handling

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

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

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

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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.

OTC - DO NOT USE SECTION

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.

OTC - WHEN USING SECTION

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

DOSAGE & ADMINISTRATION SECTION

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 SECTION

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.

STORAGE AND HANDLING SECTION

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

OTC - QUESTIONS SECTION

Questions? Contact distributor on product label for further questions.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.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
label

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80069-01380069-013-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
10acd916-20f6-4e12-a4b9-5103eec2bc504ef999e7-cdcd-4709-8257-193485e5848b2024-05-06WarningsExact identifier
spl id: 10acd916-20f6-4e12-a4b9-5103eec2bc50
spl set id: 4ef999e7-cdcd-4709-8257-193485e5848b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.