THE SOLUTION NUMBING- lidocaine hydrochloride gel

THE SOLUTION NUMBING by

Drug Labeling and Warnings

THE SOLUTION NUMBING 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 HYDROCHLORIDE 5%

PURPOSE

LOCAL ANESTHETICS

USES

• FOR THE TEMPORARY RELIEF OF DISCOMFORT AND ITCHING IN THE PERIANAL AREA HEMORRHOIDS, ANORECTAL DISORDERS, INFLAMED HEMORRHOIDAL TISSUES, ANORECTAL INFLAMMATION, HEMORRHOIDAL TISSUES OR PILES
• PAIN
• SORENESS
• BURNING

WARNINGS

STOP USE AND ASK A DOCTOR IF

• CONDITION WORSENS OR DOES NOT IMPROVE WITHIN 7 DAYS, CONSULT A PHYSICIAN; DO NOT EXCEED THE RECOMMENDED DAILY DOSAGE, UNLESS DIRECTED BY A PHYSICIAN; IN CASE OF BLEEDING, CONSULT A PHYSICIAN PROMPTLY; DO NOT PUT THIS PRODUCT INTO THE RECTUM BY USING FINGERS OR ANY MECHANICAL DEVICE OR APPLICATOR. CERTAIN PERSONS CAN DEVELOP ALLERGIC REACTIONS TO INGREDIENTS IN THIS PRODUCT. IF THE SYMPTOM BEING TREATED DOES NOT SUBSIDE OR IF REDNESS, IRRITATION, SWELLING, PAIN OR OTHER SYMPTOMS DEVELOP OR INCREASE, DISCONTINUE USE AND CONSULT A PHYSICIAN.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, CALL A POISON CONTROL CENTRE OR GET MEDICAL HELP RIGHT AWAY.

DIRECTIONS

• ADULT
• CLEANSE THE AFFECTED AREA WITH: MILD SOAP AND WARM WATER AND RINSE THOROUGHLY/BY PATTING OR BLOTTING WITH AN APPROPRIATE CLEANSING PAD.
• GENTLY DRY BY PATTING OR BLOTTING WITH TOILET TISSUE OR A SOFT CLOTH BEFORE APPLICATION OF THIS PRODUCT
• CHILDREN UNDER 12 YEARS OF AGE: CONSULT A PHYSICIAN
• APPLY EXTERNALLY TO THE AFFECTED AREA UP TO 6 TIMES DAILY
• DO NOT USE MORE OFTEN THAN DIRECTED
• GENTLY APPLY TO THE AFFECTED AREA BY PATTING AND THEN DISCARD (PAD)

OTHER INFORMATION

STORE AT ROOM TEMPERATURE (15° - 30°C)

INACTIVE INGREDIENTS

WATER/AQUA, ALCOHOL DENAT, PROPANEDIOL, ETHOXYDIGLYCOL, CARBOMER, TRIETHANOLAMINE, PHENOXYETHANOL, ETHYLHEXYLGLYCERIN

QUESTIONS?

CALL - 1 (403) 901-8244

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

THE SOLUTION NUMBING 
lidocaine hydrochloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82617-105
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

Inactive Ingredients
Ingredient Name	Strength
TROLAMINE (UNII: 9O3K93S3TK)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ALCOHOL (UNII: 3K9958V90M)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
WATER (UNII: 059QF0KO0R)
ALLANTOIN (UNII: 344S277G0Z)
PROPANEDIOL (UNII: 5965N8W85T)
CARBOMER 934 (UNII: Z135WT9208)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82617-105-60	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/12/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	05/12/2024

Labeler - SCALP TECH INC (200711913)