Active Ingredient
LIDOCAINE HCI 4%
Pomoda Dragon Pain Numbing
FDA Label NDC 65365-284
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sigan Industries Group for the product Pomoda Dragon Pain Numbing (NDC 65365-284). 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, do not use, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
TOPICAL ANALGESIC
Uses
FOR TEMPORARY RELIEF OF PAIN
Warnings
FOR EXTERNAL USE ONLY
Do Not Use
ON LARGE AREAS OF THE BODY OR ON RAW OR BLISTERED SKIN
ON WOUNDS OR DAMAGED SKIN
When Using This Product
USE ONLY AS DIRECTED.
DO NOT USE IN LARGE QUANTITIES
AVOID CONTACT WITH EYES
DO NOT APPLY TIGHT BANDAGES
DO NOT APPLY A HEATING PAD TO TREATED SKIN
Stop Use And Ask A Doctor If
CONDITIONS WORSEN OR SYMPTOMS PERSIST FOR MORE THAN 7 DAYS.
SYMPTOMS CLEAR UP AND OCCUR AGAIN WITHIN A FEW DAYS
If Pregnant Or Breast-Feeding
ASK A HEALTH PROFESSIONAL BEFORE USE
Keep Out Of Reach Of Children To Avoid Accidental Ingestion
IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY
Directions
USE ONLY AS DIRECTED
ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER: APPLY TO AFFECTED AREA NOT MORE THAN 3 TO 4 TIMES DAILY
CHILDREN UNDER 12 YEARS OF AGE: ASK A DOCTOR
Other Information
STORE AT ROOM TEMPERATURE
CLOSE CAP TIGHTLY AFTER USE
Question Sor Comments?
CALL TOLL FREE 1 877 99 GENOM (43666)
Inactive Ingredients
ACRYLATES/C10-30 ALKYL CRYLATE CROSSPOLYMER, ALCOHOL DENAT., AMINOMETHYL PROPANOL, C30-45 ALKYL CETEARLYL DIMETHICONE CROSSPOLYMER, CAPRYLYL METHICONE, CETEARYL ALCOHOL, CETETH-20 PHOSPHATE, DECOLORIZED ALOE BARBADENSIS LEAF JUICE, DICETYL PHOSPHATE DIMETHICONE, DISODIUM EDTA, ETHYLHEXYGLYCERIN, GLYCERYL STARATE SE, PHENOXYETHANOL, PURIFIED WATER, STEARETH-21
Package Label Display Panel
NEW MAX STRENGTH LIDOCAINE 4%
POMADA DRAGON PAIN NUMBING CREAM
CREMA PARA ANESTESIAR EL DOLOR LIDOCAINA HCI 4%
ORDOR FREE. NO IRRITATION, NO BURNING./ SIN OLOR. SIN IRRITACIÓN. SIN ARDOR
BLOCKS PAIN RECEPTORS/ BLOQUEA LOS RECEPTORES DEL DOLOR
NET WT 2.7 OZ (76.5g)
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