GOLD LABEL B NUMB- lidocaine hydrochloride, epinephrine hydrochloride spray 
SCALP TECH INC

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SCALP TECH (as PLD) - GOLD LABEL - B NUMB (82617-104)

ACTIVE INGREDIENT

LIDOCAINE HCL 5%

EPINEPHRINE (SUPPLIED AS EPINEPHRINE HYDROCHLORIDE) 0.01%

PURPOSE

LOCAL ANESTHETIC

USES

TEMPORARILY RELIEVES SYMPTOMS DUE TO HEMORRHOIDS, HEMORRHOIDAL TISSUES OR PILES:

WARNINGS

FOR EXTERNAL USE ONLY.

ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU HAVE

WHEN USING THIS PRODUCT DO NOT PUT INTO THE RECTUM BY USING FINGERS OR ANY MECHANICAL DEVICE OR APPLICATOR.

STOP USE AND ASK A DOCTOR IF

THESE MIGHT BE SIGNS OF METHEMOGLOBINEMIA, A RARE DISORDER, WHICH MAY APPEAR UP TO 2 HOURS AFTER USE.

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

DIRECTIONS

ADULTS AND CHILDREN 12 YEARS AND OVER

OTHER INFORMATION

INACTIVE INGREDIENTS

AQUA, ETHOXYDIGLYCOL, PHENOXYETHANOL, ALLANTOIN, ETHYLHEXYLGLYCERIN

QUESTIONS?

1 (800) 611-7720

GOLD

GOLD LABEL  B NUMB
lidocaine hydrochloride, epinephrine hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82617-104
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
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
WATER (UNII: 059QF0KO0R)  
ALLANTOIN (UNII: 344S277G0Z)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82617-104-5959 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product02/22/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01502/23/2023
Labeler - SCALP TECH INC (200711913)

Revised: 2/2024
Document Id: 12116227-89a3-3080-e063-6394a90a704d
Set id: 1211590a-13b5-2e75-e063-6394a90a0f86
Version: 1
Effective Time: 20240223
 
SCALP TECH INC