Label: THE SOLUTION- lidocaine hydrochloride, epinephrine hydrochloride spray
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- NDC Code(s): 82617-101-14
- Packager: SCALP TECH INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 July 12, 2022
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- ACTIVE INGREDIENTS
- PURPOSE
- USES
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
-
DO NOT USE THIS PRODUCT IF:
- PREGNANT OR BREASTFEEDING, ASK A HEALTH PROFESSIONAL BEFOR EUSE.
- TAMPER EVIDENT "DO NOT USE THIS PRODUCT" IF SAFETY SEAL IS BROKEN OR MISSING.
- YOU HAVE A HEART CONDITION, HIGH BLOOD PRESSURE, THYROID DISEASE, DIABETES, OR DIFFICULTY IN URINATION DUE TO ENLARGEMENT OF PROSTATE GLAND UNLESS DIRECTED BY A DOCTOR.
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WHEN USING THIS PRODUCT:
- DO NOT EXCEED THE RECOMMENDED DAILY USAGE.
- CERTAIN PERSONS CAN DEVELOP ALLERGIC REACTIONS TO INGREDIENTS IN THIS PRODUCT.
- DO NOT PUT THIS PRODUCT INTO THE RECTUM BY USING FINGERS OR ANY MEDICAL DEVICE OR APPLICATOR.
- IF SWALLOWED, CALL YOUR POISON CONTROL CENTER AT 1(800)222-1222.
- IF CONDITION WORSENS OR DOES NOT IMPROVE WITHIN 7 DAYS, CONSULT A DOCTOR.
- STOP USE AND ASK A DOCTOR IF:
-
DIRECTIONS
- CLEAN THE AFFECTED AREA.
- SENSITIVITY AND POSSIBLE ALLERGY TESTS ADVISED PRIOR TO USE. SPRAY SPARINGLY TO AFFECTED AREA AFTER THOROUGHLY CLEANSING. WAIT UNTIL ANESTHETIC EFFECT OCCURS. YOU MAY REAPPLY TO CONTINUE NUMBING AFFECT.
- APPLY TO THE AFFECTED AREA UP TO 4 TIMES DAILY.
- CHILDREN UNDER 12 YEARS OF AGE, CONSULT A DOCTOR.
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
THE SOLUTION
lidocaine hydrochloride, epinephrine hydrochloride sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82617-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 5 g in 100 mL EPINEPHRINE HYDROCHLORIDE (UNII: WBB047OO38) (EPINEPHRINE - UNII:YKH834O4BH) EPINEPHRINE HYDROCHLORIDE 0.01 g in 100 mL Inactive Ingredients Ingredient Name Strength CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) WATER (UNII: 059QF0KO0R) ALLANTOIN (UNII: 344S277G0Z) PROPANEDIOL (UNII: 5965N8W85T) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82617-101-14 118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 04/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M015 04/01/2022 Labeler - SCALP TECH INC (200711913)
