FDA Label for Gold Label B Numb
View Indications, Usage & Precautions
Gold Label B Numb Product Label
The following document was submitted to the FDA by the labeler of this product Scalp Tech Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
LIDOCAINE HCL 5%
EPINEPHRINE (SUPPLIED AS EPINEPHRINE HYDROCHLORIDE) 0.01%
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?
1 (800) 611-7720
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