THE SOLUTION- lidocaine hydrochloride, epinephrine hydrochloride spray 
SCALP TECH INC

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.

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SCALP TECH - THE SOLUTION (82617-101)

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

KEEP OUT OF REACH OF CHILDREN.

DO NOT USE THIS PRODUCT IF:

WHEN USING THIS PRODUCT:

STOP USE AND ASK A DOCTOR IF:

DIRECTIONS

OTHER INFORMATION

INACTIVE INGREDIENTS

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

QUESTIONS?

CALL - 1 (403) 901-8244

01b LBL_The Solution Art Work_4oz

THE SOLUTION 
lidocaine hydrochloride, epinephrine hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82617-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS5 g  in 100 mL
EPINEPHRINE HYDROCHLORIDE (UNII: WBB047OO38) (EPINEPHRINE - UNII:YKH834O4BH) EPINEPHRINE HYDROCHLORIDE0.01 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82617-101-14118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product04/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM01504/01/2022
Labeler - SCALP TECH INC (200711913)

Revised: 7/2022
Document Id: e3a19179-9b3f-a032-e053-2995a90a0917
Set id: df51623c-e0b6-8e86-e053-2995a90a59b2
Version: 2
Effective Time: 20220712
 
SCALP TECH INC