THE SOLUTION- lidocaine hydrochloride, epinephrine hydrochloride spray

THE SOLUTION by

Drug Labeling and Warnings

THE SOLUTION by is a Otc medication manufactured, distributed, or labeled by SCALP TECH INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

LIDOCAINE HCL 5%

EPINEPHRINE HCL .01%

PURPOSE

LOCAL ANESTHETICS

VASOCONSTRICTOR

USES

FOR THE TEMPORARY RELIEF OF LOCAL AND ANORECTAL ITCHING, DISCOMFORT, AND PAIN ASSOCIATED WITH ANORECTAL DISORDERS OR ANORECTAL INFLAMMATION.

WARNINGS

• FOR EXTERNAL USE ONLY.
• AVOID CONTACT WITH THE EYES.

KEEP OUT OF REACH OF CHILDREN

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.

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:

• THE SYMPTOM BEING TREATED DOES NOT SUBSIDE, OR REDNESS, IRRITATION, SWELLING, PAIN, OR OTHER SYMPTOMS DEVELOP OR INCREASE.

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

• STORE IN COOL DARK PLACE OR REFRIGERATE.
• KEEP AWAY FROM DIRECT SUNLIGHT OR HEAT.
• DISCARD AFTER EXPIRATION DATE.

INACTIVE INGREDIENTS

ALLANTOIN, CAPRYLHYDOXAMIC ACID, ETHOXYDIGLYCOL, 1,2-HEXANEDIOL, PROPANEDIOL, WATER

QUESTIONS?

CALL - 1 (403) 901-8244

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

THE SOLUTION 
lidocaine hydrochloride, epinephrine hydrochloride spray

Product 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 Drug	M015	04/01/2022

Labeler - SCALP TECH INC (200711913)