SJ3- lidocaine hcl, tetracaine hcl, benzocaine spray

SJ3 by

Drug Labeling and Warnings

SJ3 by is a Otc medication manufactured, distributed, or labeled by Dermal Source, Inc., HTO Nevada, Inc. (dba Kirkman). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

INDICATIONS & USAGE

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

WARNINGS

WARNINGS -  Keep out reach of children

DO NOT USE

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.

WHEN USING

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

STOP USE

KEEP OUT OF REACH OF CHILDREN

DOSAGE & ADMINISTRATION

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

Inactive Ingredients: Propylene Glycol, Ethoxydiglycol, Tetrasodium EDTA.

STORAGE AND HANDLING

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

QUESTIONS

Questions? Contact distributor on product 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

INGREDIENTS AND APPEARANCE

SJ3 
lidocaine hcl, tetracaine hcl, benzocaine spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80069-011
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 mL
Tetracaine Hydrochloride (UNII: 5NF5D4OPCI) (Tetracaine - UNII:0619F35CGV)	Tetracaine Hydrochloride	10 mg  in 1 mL
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5)	Benzocaine	120 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Propylene Glycol (UNII: 6DC9Q167V3)
Diethylene Glycol Monoethyl Ether (UNII: A1A1I8X02B)
Edetate Sodium (UNII: MP1J8420LU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80069-011-01	118.294 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/15/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	08/15/2021

Labeler - Dermal Source, Inc. (183535629)

Establishment
Name	Address	ID/FEI	Business Operations
HTO Nevada, Inc. (dba Kirkman)		117115846	manufacture(80069-011)