Drug Facts - For use by licensed professionals only

SJ3 by

Drug Labeling and Warnings

SJ3 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]

SJ3- lidocaine hcl, tetracaine hcl, benzocaine spray 
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 Ingredients		Purpose
Lidocaine Hydrochloride	4%	Topical Anesthetic
Tetracaine Hydrochloride	2%	Topical Anesthetic
Benzocaine	12%	Topical Anesthetic

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

WARNINGS: Keep out reach of children

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

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 Ingredients: Propylene Glycol, Ethoxydiglycol, Tetrasodium EDTA.

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

Questions?
Contact distributor on product label.

PRINCIPAL DISPLAY PANEL

SJ3

SuperJuice 3

Anesthetic for use during painful procedures.

Contains 4 oz.

Distributed by: DERMAL SOURCE
Portland, OR 97232
www.dermalsource.com
1-866-568-3223

SP2268-4

SJ3 
lidocaine hcl, tetracaine hcl, benzocaine spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80069-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Lidocaine Hydrochloride (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987)	Lidocaine Hydrochloride Anhydrous	40 mg  in 1 mL
Tetracaine Hydrochloride (UNII: 5NF5D4OPCI) (Tetracaine - UNII:0619F35CGV)	Tetracaine Hydrochloride	20 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: 80069-005-01	118.294 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/01/2004	08/17/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	07/01/2004	08/17/2021

Labeler - Dermal Source, Inc. (183535629)

Establishment
Name	Address	ID/FEI	Business Operations
KIRKMAN GROUP, INC.		078525382	manufacture(80069-005)

Revised: 7/2021

Document Id: 19607380-4e46-4f22-b9cb-e118a8fea2d2

34390-5

Set id: 0a5618bc-69e4-47b6-9b86-f1578ee9c87a

Version: 2

Effective Time: 20210716