Unburn (Lidocaine Hydrochloride) Spray [Water-Jel Technologies] -

UNBURN (LIDOCAINE HYDROCHLORIDE) SPRAY [WATER-JEL TECHNOLOGIES]
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NDC	59898-510-45
Set ID	40164231-1556-4714-9e27-9d41e3c71447
Category	HUMAN OTC DRUG LABEL
Packager	Water-Jel Technologies
Generic Name
Product Class	Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number	PART348

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Active ingredient

Lidocaine HCl 2.5%
Purpose

External analgesic
Uses
for the temporary relief of pain associated with:
- sunburn
- minor burns
- minor skin irritations
- insect bites
Warnings
For external use only
Do not use
- in large quantities, particularly over raw surfaces or blistered areas
When using this product
- avoid contact with eyes
Stop use and ask a doctor if
- condition worsens
- symptoms persist for more than 7 days
- condition clears up and occurs again within a few days
Keep out of the reach of children

If swallowed, get medical help or contact a Poison Control Center right away.
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 o to 25 oC (59 o to 77 oF)
- do not freeze
- you may report a serious adverse reaction to this product to 1-800-275-3433
Inactive ingredients

acrylates/C20-30 alkyl acrylate crosspolymer, aloe, caprylyl glycol, carbomer, chlorophenesin, edetate disodium, glyceryl-7 stearate, octoxynol-9, polysorbate 20, phenoxyethanol, purified water, spearmint oil, tea tree oil, trolamine, vitamin E acetate
QUESTIONS

1-800-275-3433info@waterjel.com www.waterjel.com
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INGREDIENTS AND APPEARANCE

UNBURN
lidocaine hydrochloride spray

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	2.5 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
ALOE (UNII: V5VD430YW9)
CAPRYLIC ALCOHOL (UNII: NV1779205D)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
CHLORPHENESIN (UNII: I670DAL4SZ)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
OCTOXYNOL-9 (UNII: 7JPC6Y25QS)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)
SPEARMINT OIL (UNII: C3M81465G5)
TEA TREE OIL (UNII: VIF565UC2G)
TROLAMINE (UNII: 9O3K93S3TK)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:59898-510-45	150 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	02/01/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	02/01/2014

Labeler - Water-Jel Technologies (155522589)

Name	Address	ID/FEI	Business Operations
Establishment
Water-Jel Technologies		155522589	manufacture(59898-510)

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Medic