GOLD LABEL B NUMB- lidocaine hydrochloride, epinephrine hydrochloride spray

GOLD LABEL by

Drug Labeling and Warnings

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

Drug Details [pdf]

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:

• ITCHING
• PAIN
• SORENESS
• BURNING

WARNINGS

FOR EXTERNAL USE ONLY.

ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU HAVE

• HEART DISEASE
• HIGH BLOOD PLESSURE
• THYROID DISEASE
• DIABETES
• DIFFICULTY IN URINATION
• TAKE MEDICINE FOR
• HIGH BLOOD PRESSURE
• DEPRESSION

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

• BLEEDING OCCURS
• CONDITION WORSENS OR DOES NOT IMPROVE WITHIN 7 DAYS
• REDNESS, IRRITATION, SWELLING, PAIN OR OTHER SYMPTOMS OCCUR
• YOU EXPERIENCE
• WEAKNESS
• CONFUSION
• HEADACHE
• DIFFICULTY BREATHING
• PALE, GREY OR BLUE COLOURED SKIN.

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

KEEP OUT OF REACH OF CHILDREN

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

• CLEANSE THE AFFECTED AREA WITH MILD SOAP AND WARM WATER
• RINSE WELL OR PAT WITH AN APPROPRIATE CLEANSING PAD
• GENTLY DRY BY PATTING OR BLOTTING WITH TOILET TISSUE OR A SOFT CLOTH BEFORE APPLYING THIS PRODUCT
• USE SPRAY PUMP TO APPLY EXTERNALLY TO THE AFFECTED AREA UP TO 4 TIMES DAILY
• DO NOT USE MORE OFTEN THAN DIRECTED

OTHER INFORMATION

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

INACTIVE INGREDIENTS

AQUA, ETHOXYDIGLYCOL, PHENOXYETHANOL, ALLANTOIN, ETHYLHEXYLGLYCERIN

QUESTIONS?

1 (800) 611-7720

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GOLD LABEL  B NUMB
lidocaine hydrochloride, epinephrine hydrochloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82617-104
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
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
WATER (UNII: 059QF0KO0R)
ALLANTOIN (UNII: 344S277G0Z)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82617-104-59	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	02/22/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M015	02/23/2023

Labeler - SCALP TECH INC (200711913)