SJ3

Manufacturer
Dermal Source, Inc. | HTO Nevada, Inc. (dba Kirkman)
Effective date
2024-05-06
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:03:45

Label at a glance#

ProductSJ3
Active ingredientLidocaine Hydrochloride, Tetracaine Hydrochloride, Benzocaine
Label structure10 sections

Storage and handling

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

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active Ingredients  Purpose
Lidocaine Hydrochloride   5% Topical Anesthetic
Tetracaine Hydrochloride   1% Topical Anesthetic
Benzocaine 12% Topical Anesthetic

INDICATIONS & USAGE SECTION

Uses: External Use Only. Do Not Swallow. Temporarily supplies pain relief to either intact or open skin due to pain sensitive procedures.

WARNINGS SECTION

WARNINGS -  Keep out reach of children

OTC - DO NOT USE SECTION

Do not use if you have

  • seizures or liver disease
  • if pregnant or breast feeding
  • a known allergy or sensitivity to any of the components of this product. If sensitivity occurs, discontinue use, and seek medical attention. If condition worsens or symptoms persist for more than seven days or clear up and occur again within a few days, discontinue use of this product and consult a doctor. Do not use in large quantities, particularly over raw surfaces or blistered areas.

Avoid contact with eyes, in case of accidental contact with eyes, rinse immediately with copious amounts of eyewash and seek treatment by an eye care specialist. If accidentally swallowed, get medical help immediately.

OTC - WHEN USING SECTION

When using this product you may notice temporary blanching or redness of the skin where liquid is applied.

DOSAGE & ADMINISTRATION SECTION

Directions:  Sensitivity test advised prior to use.

Apply to intact skin to clean prior to application of predeadener. Use to wipe off predeadener. During procedure, swipe across skin and wait for numbness to develop (90 seconds). Not appropriate for eyeliner. You may reapply as necessary to continue anesthesia. Discontinue use if sensitivity occurs. Remove product before continuing with procedure.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Propylene Glycol, Ethoxydiglycol, Tetrasodium EDTA.

STORAGE AND HANDLING SECTION

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

OTC - QUESTIONS SECTION

Questions? Contact distributor on product label.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SUPERIOR

SJ3

SuperJuice 3

anesthetic for use during a pain sensitive procedure

4 oz.

Distributed by: DERMAL SOURCE
Portland, OR 97232

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

label
label

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80069-01180069-011-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 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
b7a2403b-c1cc-426c-b6da-187f00c74057f26ffe2e-7bb0-4280-8b54-a5d8c086f04c2024-05-06WarningsExact identifier
spl id: b7a2403b-c1cc-426c-b6da-187f00c74057
spl set id: f26ffe2e-7bb0-4280-8b54-a5d8c086f04c

Reported adverse events (FAERS/openFDA)#

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