Scalp Tech (as Pld) - Gold Label - B Numb (82617-104)

SPL v1

SPL

SPL Set ID 1211590a-13b5-2e75-e063-6394a90a0f86

Route

TOPICAL

Published

Effective Date 2024-02-23

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Epinephrine (5 g)

Inactive Ingredients

Phenoxyethanol Diethylene Glycol Monoethyl Ether Water Allantoin Ethylhexylglycerin

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-02-23

Description

LIDOCAINE HCL 5% EPINEPHRINE (SUPPLIED AS EPINEPHRINE HYDROCHLORIDE) 0.01%

Purpose

LOCAL ANESTHETIC

Medication Information

Purpose

LOCAL ANESTHETIC

Description

LIDOCAINE HCL 5% EPINEPHRINE (SUPPLIED AS EPINEPHRINE HYDROCHLORIDE) 0.01%

Uses

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

ITCHING
PAIN
SORENESS
BURNING

Section 50565-1

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

Section 51945-4

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.

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

Questions?

1 (800) 611-7720

Active Ingredient

LIDOCAINE HCL 5%

EPINEPHRINE (SUPPLIED AS EPINEPHRINE HYDROCHLORIDE) 0.01%

Other Information

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

Inactive Ingredients

AQUA, ETHOXYDIGLYCOL, PHENOXYETHANOL, ALLANTOIN, ETHYLHEXYLGLYCERIN

Structured Label Content

Uses (USES)

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

ITCHING
PAIN
SORENESS
BURNING

Section 50565-1 (50565-1)

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

Section 51945-4 (51945-4)

Purpose (PURPOSE)

LOCAL ANESTHETIC

Warnings (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.

Directions (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

Questions? (QUESTIONS?)

1 (800) 611-7720

Active Ingredient (ACTIVE INGREDIENT)

LIDOCAINE HCL 5%

EPINEPHRINE (SUPPLIED AS EPINEPHRINE HYDROCHLORIDE) 0.01%

Other Information (OTHER INFORMATION)

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

Inactive Ingredients (INACTIVE INGREDIENTS)

AQUA, ETHOXYDIGLYCOL, PHENOXYETHANOL, ALLANTOIN, ETHYLHEXYLGLYCERIN

Advanced Ingredient Data

[{"name": "PHENOXYETHANOL", "unii": "HIE492ZZ3T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIETHYLENE GLYCOL MONOETHYL ETHER", "unii": "A1A1I8X02B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALLANTOIN", "unii": "344S277G0Z", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ETHYLHEXYLGLYCERIN", "unii": "147D247K3P", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LIDOCAINE HYDROCHLORIDE ANHYDROUS", "unii": "EC2CNF7XFP", "classCode": "ACTIR", "strengthNumerator": "5", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "EPINEPHRINE", "unii": "YKH834O4BH", "classCode": "ACTIB", "strengthNumerator": "0.01", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"USES": "TEMPORARILY RELIEVES SYMPTOMS DUE TO HEMORRHOIDS, HEMORRHOIDAL TISSUES OR PILES: ITCHING PAIN SORENESS BURNING", "50565-1": "KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, CALL A POISON CONTROL CENTER OR GET MEDICAL HELP RIGHT AWAY.", "PURPOSE": "LOCAL ANESTHETIC", "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.", "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", "QUESTIONS?": "1 (800) 611-7720", "ACTIVE INGREDIENT": "LIDOCAINE HCL 5% EPINEPHRINE (SUPPLIED AS EPINEPHRINE HYDROCHLORIDE) 0.01%", "OTHER INFORMATION": "STORE AT ROOM TEMPERATURE (15° - 30°C)", "INACTIVE INGREDIENTS": "AQUA, ETHOXYDIGLYCOL, PHENOXYETHANOL, ALLANTOIN, ETHYLHEXYLGLYCERIN"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:02:48.464737 · Updated: 2026-03-14T23:02:33.495898