Active Ingredients
LIDOCAINE HCL 5%
EPINEPHRINE HCL .01%
The Solution Spray
FDA Label NDC 82617-101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Scalp Tech Inc for the product The Solution (NDC 82617-101). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, otc - keep out of reach of children, do not use this product if:, when using this product:, stop use and ask a doctor if:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
LOCAL ANESTHETICS
VASOCONSTRICTOR
Uses
FOR THE TEMPORARY RELIEF OF LOCAL AND ANORECTAL ITCHING, DISCOMFORT, AND PAIN ASSOCIATED WITH ANORECTAL DISORDERS OR ANORECTAL INFLAMMATION.
Warnings
- FOR EXTERNAL USE ONLY.
- AVOID CONTACT WITH THE EYES.
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN.
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.
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.
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.
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.
Other Information
- STORE IN COOL DARK PLACE OR REFRIGERATE.
- KEEP AWAY FROM DIRECT SUNLIGHT OR HEAT.
- DISCARD AFTER EXPIRATION DATE.
Inactive Ingredients
ALLANTOIN, CAPRYLHYDOXAMIC ACID, ETHOXYDIGLYCOL, 1,2-HEXANEDIOL, PROPANEDIOL, WATER
Questions?
CALL - 1 (403) 901-8244
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