DRAGON PAIN NUMBING TOPICAL ANALGESIC- lidocaine hydrochloride cream 
Genomma Lab USA Inc.

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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Dragon® Pain Numbing Cream

Drug Facts

Active ingredient

Lidocaine HCl 4%

Purpose

Topical analgesic

Uses

for the 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

Inactive ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Alcohol denat., Aminomethyl propanol, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Caprylyl Methicone, Cetearyl Alcohol, Ceteth-20 Phosphate, Decolorized Aloe barbadensis leaf juice, Dicetyl Phosphate, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Glyceryl Stearare SE, Phenoxyethanol, Steareth-21, Water

Questions or comments?

Call toll free 1 877 99 GENOM (43666)

Distributed by:
Genomma Lab USA, Inc.,
Houston, TX 77027

PRINCIPAL DISPLAY PANEL - 76.5 g Bottle Carton

POMADA
DRAGON®

LIDOCAINE HCl 4%
MAX STRENGTH

PAIN NUMBING CREAM

BLOCKS PAIN RECEPTORS

Numbs pain fast

Hours of relief

Odor free

NET. WT 2.7 oz (76.5 g)

PRINCIPAL DISPLAY PANEL - 76.5 g Bottle Carton
DRAGON PAIN NUMBING  TOPICAL ANALGESIC
lidocaine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-056
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
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
ALCOHOL (UNII: 3K9958V90M)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
Ceteth-20 Phosphate (UNII: 921FTA1500)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
Dimethicone (UNII: 92RU3N3Y1O)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Ethylhexylglycerin (UNII: 147D247K3P)  
Glyceryl Stearate SE (UNII: FCZ5MH785I)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Steareth-21 (UNII: 53J3F32P58)  
Water (UNII: 059QF0KO0R)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50066-056-011 in 1 CARTON09/07/2017
176.5 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/07/2017
Labeler - Genomma Lab USA Inc. (832323534)
Registrant - Garcoa, Inc. (036464697)
Establishment
NameAddressID/FEIBusiness Operations
Sigan Industries INC255106239MANUFACTURE(50066-056) , LABEL(50066-056) , PACK(50066-056)

Revised: 2/2023
Document Id: afbcca7e-083e-4e72-b568-47e7e624dd63
Set id: dbd5dc3e-206e-4c3f-b675-266f43a60e11
Version: 3
Effective Time: 20230221
 
Genomma Lab USA Inc.