Label: SJ3- lidocaine hcl, tetracaine hcl, benzocaine spray
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- NDC Code(s): 80069-011-01
- Packager: Dermal Source, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated June 30, 2022
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- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- WARNINGS
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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
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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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
- STORAGE AND HANDLING
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SJ3
lidocaine hcl, tetracaine hcl, benzocaine sprayProduct 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 not final part348 08/15/2021 Labeler - Dermal Source, Inc. (183535629) Establishment Name Address ID/FEI Business Operations HTO Nevada, Inc. (dba Kirkman) 117115846 manufacture(80069-011)
