Active Ingredient
LIDOCAINE HCL 5%
The Solution 2.0 Spray
FDA Label NDC 82617-102
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 2.0 (NDC 82617-102). 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 ingredient, purpose, uses, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
- 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.
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
tHESE MIGHT BE SIGNS OF METHEMOGLOBINEMIA, A RARE DISORDER, WHICH MAY APPEAR UP TO 2 HOURS AFTER USE.
Otc - 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?
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