FDA Label for Sj3
View Indications, Usage & Precautions
Sj3 Product Label
The following document was submitted to the FDA by the labeler of this product Dermal Source, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Otc - Purpose
| 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
Otc - 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.
Otc - When Using
When using this product you may notice temporary blanching or redness of the skin where liquid is applied.
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.
Otc - 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
* Please review the disclaimer below.