Label: GOLD LABEL B NUMB- lidocaine hydrochloride, epinephrine hydrochloride spray
- NDC Code(s): 82617-104-59
- Packager: SCALP TECH INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated February 23, 2024
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- ACTIVE INGREDIENT
- PURPOSE
- USES
-
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
-
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
- INACTIVE INGREDIENTS
- QUESTIONS?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
GOLD LABEL B NUMB
lidocaine hydrochloride, epinephrine hydrochloride sprayProduct 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)
