Scalp Tech (as Pld) - The Solution (82617-101)

Scalp Tech (as Pld) - The Solution (82617-101)
SPL v4
SPL
SPL Set ID df51623c-e0b6-8e86-e053-2995a90a59b2
Route
TOPICAL
Published
Effective Date 2022-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Epinephrine (5 g)
Inactive Ingredients
Caprylhydroxamic Acid Diethylene Glycol Monoethyl Ether Water Allantoin Propanediol 1,2-hexanediol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-04-01

Description

LIDOCAINE HCL 5% EPINEPHRINE HCL .01%

Purpose

LOCAL ANESTHETICS VASOCONSTRICTOR


Medication Information

Purpose

LOCAL ANESTHETICS

VASOCONSTRICTOR

Description

LIDOCAINE HCL 5% EPINEPHRINE HCL .01%

Uses

FOR THE TEMPORARY RELIEF OF LOCAL AND ANORECTAL ITCHING, DISCOMFORT, AND PAIN ASSOCIATED WITH ANORECTAL DISORDERS OR ANORECTAL INFLAMMATION.

Section 50565-1

KEEP OUT OF REACH OF CHILDREN.

Section 51945-4

Warnings
  • FOR EXTERNAL USE ONLY.
  • AVOID CONTACT WITH THE EYES.
Directions
  • CLEAN THE AFFECTED AREA.
  • SENSITIVITY AND POSSIBLE ALLERGY TESTS ADVISED PRIOR TO USE. SPRAY SPARINGLY TO AFFECTED AREA AFTER THOROUGHLY CLEANSING. WAIT UNTIL ANESTHETIC EFFECT OCCURS. YOU MAY REAPPLY TO CONTINUE NUMBING AFFECT.
  • APPLY TO THE AFFECTED AREA UP TO 4 TIMES DAILY.
  • CHILDREN UNDER 12 YEARS OF AGE, CONSULT A DOCTOR.
Questions?

CALL - 1 (403) 901-8244

Other Information
  • STORE IN COOL DARK PLACE OR REFRIGERATE.
  • KEEP AWAY FROM DIRECT SUNLIGHT OR HEAT.
  • DISCARD AFTER EXPIRATION DATE.
Active Ingredients

LIDOCAINE HCL 5%

EPINEPHRINE HCL .01%

Inactive Ingredients

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

When Using This Product:
  • DO NOT EXCEED THE RECOMMENDED DAILY USAGE.
  • CERTAIN PERSONS CAN DEVELOP ALLERGIC REACTIONS TO INGREDIENTS IN THIS PRODUCT.
  • DO NOT PUT THIS PRODUCT INTO THE RECTUM BY USING FINGERS OR ANY MEDICAL DEVICE OR APPLICATOR.
  • IF SWALLOWED, CALL YOUR POISON CONTROL CENTER AT 1(800)222-1222.
  • IF CONDITION WORSENS OR DOES NOT IMPROVE WITHIN 7 DAYS, CONSULT A DOCTOR.
Do Not Use This Product If:
  • PREGNANT OR BREASTFEEDING, ASK A HEALTH PROFESSIONAL BEFOR EUSE.
  • TAMPER EVIDENT "DO NOT USE THIS PRODUCT" IF SAFETY SEAL IS BROKEN OR MISSING.
  • YOU HAVE A HEART CONDITION, HIGH BLOOD PRESSURE, THYROID DISEASE, DIABETES, OR DIFFICULTY IN URINATION DUE TO ENLARGEMENT OF PROSTATE GLAND UNLESS DIRECTED BY A DOCTOR.
Stop Use and Ask A Doctor If:
  • THE SYMPTOM BEING TREATED DOES NOT SUBSIDE, OR REDNESS, IRRITATION, SWELLING, PAIN, OR OTHER SYMPTOMS DEVELOP OR INCREASE.

Structured Label Content

Uses (USES)

FOR THE TEMPORARY RELIEF OF LOCAL AND ANORECTAL ITCHING, DISCOMFORT, AND PAIN ASSOCIATED WITH ANORECTAL DISORDERS OR ANORECTAL INFLAMMATION.

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN.

Section 51945-4 (51945-4)

Purpose (PURPOSE)

LOCAL ANESTHETICS

VASOCONSTRICTOR

Warnings (WARNINGS)
  • FOR EXTERNAL USE ONLY.
  • AVOID CONTACT WITH THE EYES.
Directions (DIRECTIONS)
  • CLEAN THE AFFECTED AREA.
  • SENSITIVITY AND POSSIBLE ALLERGY TESTS ADVISED PRIOR TO USE. SPRAY SPARINGLY TO AFFECTED AREA AFTER THOROUGHLY CLEANSING. WAIT UNTIL ANESTHETIC EFFECT OCCURS. YOU MAY REAPPLY TO CONTINUE NUMBING AFFECT.
  • APPLY TO THE AFFECTED AREA UP TO 4 TIMES DAILY.
  • CHILDREN UNDER 12 YEARS OF AGE, CONSULT A DOCTOR.
Questions? (QUESTIONS?)

CALL - 1 (403) 901-8244

Other Information (OTHER INFORMATION)
  • STORE IN COOL DARK PLACE OR REFRIGERATE.
  • KEEP AWAY FROM DIRECT SUNLIGHT OR HEAT.
  • DISCARD AFTER EXPIRATION DATE.
Active Ingredients (ACTIVE INGREDIENTS)

LIDOCAINE HCL 5%

EPINEPHRINE HCL .01%

Inactive Ingredients (INACTIVE INGREDIENTS)

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

When Using This Product: (WHEN USING THIS PRODUCT:)
  • DO NOT EXCEED THE RECOMMENDED DAILY USAGE.
  • CERTAIN PERSONS CAN DEVELOP ALLERGIC REACTIONS TO INGREDIENTS IN THIS PRODUCT.
  • DO NOT PUT THIS PRODUCT INTO THE RECTUM BY USING FINGERS OR ANY MEDICAL DEVICE OR APPLICATOR.
  • IF SWALLOWED, CALL YOUR POISON CONTROL CENTER AT 1(800)222-1222.
  • IF CONDITION WORSENS OR DOES NOT IMPROVE WITHIN 7 DAYS, CONSULT A DOCTOR.
Do Not Use This Product If: (DO NOT USE THIS PRODUCT IF:)
  • PREGNANT OR BREASTFEEDING, ASK A HEALTH PROFESSIONAL BEFOR EUSE.
  • TAMPER EVIDENT "DO NOT USE THIS PRODUCT" IF SAFETY SEAL IS BROKEN OR MISSING.
  • YOU HAVE A HEART CONDITION, HIGH BLOOD PRESSURE, THYROID DISEASE, DIABETES, OR DIFFICULTY IN URINATION DUE TO ENLARGEMENT OF PROSTATE GLAND UNLESS DIRECTED BY A DOCTOR.
Stop Use and Ask A Doctor If: (STOP USE AND ASK A DOCTOR IF:)
  • THE SYMPTOM BEING TREATED DOES NOT SUBSIDE, OR REDNESS, IRRITATION, SWELLING, PAIN, OR OTHER SYMPTOMS DEVELOP OR INCREASE.

Advanced Ingredient Data


Raw Label Data

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