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., HTO Nevada, Inc. (dba Kirkman). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SJ3- lidocaine hcl, tetracaine hcl, benzocaine spray 
Dermal Source, Inc.

----------

Drug Facts - For use by licensed professionals only


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

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
SJ3 
lidocaine hcl, tetracaine hcl, benzocaine spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 80069-011
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Lidocaine Hydrochloride (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987) Lidocaine Hydrochloride Anhydrous50 mg  in 1 mL
Tetracaine Hydrochloride (UNII: 5NF5D4OPCI) (Tetracaine - UNII:0619F35CGV) Tetracaine Hydrochloride10 mg  in 1 mL
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine120 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Propylene Glycol (UNII: 6DC9Q167V3)  
Diethylene Glycol Monoethyl Ether (UNII: A1A1I8X02B)  
Edetate Sodium (UNII: MP1J8420LU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 80069-011-01118.294 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/15/202111/25/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01708/15/202111/25/2024
Labeler - Dermal Source, Inc. (183535629)
Establishment
NameAddressID/FEIBusiness Operations
HTO Nevada, Inc. (dba Kirkman)117115846manufacture(80069-011)

Revised: 5/2024
 

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.