DRAGON PAIN NUMBING TOPICAL ANALGESIC- lidocaine hydrochloride cream

Dragon Pain Numbing by

Drug Labeling and Warnings

Dragon Pain Numbing by is a Otc medication manufactured, distributed, or labeled by Genomma Lab USA Inc., Garcoa, Inc., Sigan Industries INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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)

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

PRINCIPAL DISPLAY PANEL - 76.5 g Bottle Carton

NEW
MAX STRENGTH
LIDOCAINE 4%

POMADA
DRAGON®
PAIN NUMBING CREAM

Odor Free No Irritation No Burning

BLOCKS PAIN RECEPTORS

NET WT
2.7 oz (76.5 g)

INGREDIENTS AND APPEARANCE

DRAGON PAIN NUMBING  TOPICAL ANALGESIC
lidocaine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50066-056
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	40 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50066-056-01	1 in 1 CARTON	09/07/2017
1		76.5 g in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/07/2017

Labeler - Genomma Lab USA Inc. (832323534)

Registrant - Garcoa, Inc. (036464697)

Establishment
Name	Address	ID/FEI	Business Operations
Garcoa, Inc.		036464697	MANUFACTURE(50066-056)