POMODA DRAGON PAIN NUMBING- pomoda dragon pain numbing cream 
SIGAN INDUSTRIES GROUP

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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MAX STRENGTH POMADA DRAGON PAIN NUMBING CREAM

ACTIVE INGREDIENT

LIDOCAINE HCI 4%

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 IRRITACIÓ​N. SIN ARDOR

BLOCKS PAIN RECEPTORS/ BLOQUEA LOS RECEPTORES DEL DOLOR

NET WT 2.7 OZ (76.5g)

284-06284-01

POMODA DRAGON PAIN NUMBING 
pomoda dragon pain numbing cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65365-284
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
CETETH-20 PHOSPHATE (UNII: 921FTA1500)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
WATER (UNII: 059QF0KO0R)  
STEARETH-21 (UNII: 53J3F32P58)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65365-284-061 in 1 CARTON08/16/2017
1NDC:65365-284-0176.5 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/16/2017
Labeler - SIGAN INDUSTRIES GROUP (251829404)
Registrant - SIGAN INDUSTRIES INC (255106239)

Revised: 7/2017
Document Id: 56ef22ac-4225-0970-e054-00144ff88e88
Set id: 56ef22ac-4226-0970-e054-00144ff88e88
Version: 1
Effective Time: 20170731
 
SIGAN INDUSTRIES GROUP