BURNX PAIN RELIEVING BURN- lidocaine hydrochloride gel

BurnX by

Drug Labeling and Warnings

BurnX by is a Otc medication manufactured, distributed, or labeled by Natureplex, LLC, Natureplex LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Lidocaine hydrochloride 2.5%

Purpose

Topical analgesic

Use

for the temporary relief of pain associated with minor burns, sunburn, and minor skin irritations

Warnings

For external use only.

Avoid contact with eyes.

Not for prolonged use.

Do not use in large quantities, particularly over raw surfaces or blistered areas.

Stop use and ask a doctor if

• condition worsens
• symptoms persist for more than 7 days or clear up and occurs again within a few days
• rash or irritation develops, persists, or increases

If pregnant or breast-feeding, ask a health professional before use.

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

Directions

Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily

Children under 2 years of age: Consult a doctor

Other Information

• store at 15 to 30° C (59 to 86° F)
• Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.

Inactive Ingredients

Carbomer, disodium EDTA, glycerin, melaleuca alternifolia (tea tree) leaf oil, octoxynol-9, propylene glycol (and) diazolidinyl urea (and) methylparaben (and) propylparaben, purified water, triethanolamine

Questions or comments?

866-323-0107 or www.natureplex.com

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

Natureplex™

PAIN RELIEVING BURN GEL
NDC: 67234-037-01

BurnX™
LIDOCAINE HCL 2.5%
Topical Analgesic

For Burns and
Sunburns

NET WT. 1 Oz.(28g)

INGREDIENTS AND APPEARANCE

BURNX   PAIN RELIEVING BURN
lidocaine hydrochloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67234-037
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	0.025 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
TEA TREE OIL (UNII: VIF565UC2G)
OCTOXYNOL-9 (UNII: 7JPC6Y25QS)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67234-037-01	1 in 1 CARTON	04/10/2010
1		28 g in 1 TUBE; 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	04/10/2010

Labeler - Natureplex, LLC (062808196)

Establishment
Name	Address	ID/FEI	Business Operations
Natureplex LLC		062808196	MANUFACTURE(67234-037)