Fsk-5 (Lidocaine Hydrochloride) Kit [Water-Jel Technologies] -

FSK-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]
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NDC	59898-170-43, 59898-200-15, 59898-200-35
Set ID	4c62196a-9f94-4823-b95f-447f012f10bf
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 2.0 %
Purpose

External analgesic
Uses

for the temporary relief of pain associated with minor burns
Warnings
For external use only

Do not use

on large areas of the body

on broken, blistered or oozing skin
When using this product
- avoid contact with eyes
Stop use and ask a doctor if
- conditions worsens
- symptoms persist for more than 7 days
- symptoms clears up and occur again in 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
- spread a thick even layer over affected skin
- children under 2 years of age: consult a doctor
Other information
- store at room temperature
- do not use packeet if opened or torn
- you may report a serious adverse reaction to this product to 800-275-3433
Inactive ingredients

triethanolamine, meleleuca alternifolia (tea tree) leaf oil, glycerin, propylene glycol, diazolidinyl urea, methylparaben, propylparaben, carbomer, octoxynol-9, acrylates C/10-30 alkyl acrylate, disodium EDTA
Questions

1-800-275-3433 www.waterjel.com
SPL UNCLASSIFIED SECTION

MEDICAL DEVICES
2 2" x 6" Burn Dressings
2 4" x 4" Burn Dressings
1 12" x 16" Face Mask
1 2" x 2.2 yd Elastic Bandage
Principal Display Panel
Principal Display Panel Packet

INGREDIENTS AND APPEARANCE

FSK-5
lidocaine hydrochloride kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59898-170

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:59898-170-43	1 in 1 KIT	06/11/2014

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	25 PACKET	87.5 mL

Part 1 of 1

BURN JEL
lidocaine hydrochloride gel

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	2 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
METHYLPARABEN (UNII: A2I8C7HI9T)
TEA TREE OIL (UNII: VIF565UC2G)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
TROLAMINE (UNII: 9O3K93S3TK)
OCTOXYNOL-9 (UNII: 7JPC6Y25QS)
CARBOMER HOMOPOLYMER TYPE B (UNII: HHT01ZNK31)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
EDETATE DISODIUM (UNII: 7FLD91C86K)

#	Item Code	Package Description
Packaging
1	NDC:59898-200-15	25 in 1 CARTON
1	NDC:59898-200-35	3.5 mL in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	06/11/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	06/11/2014

Labeler - Water-Jel Technologies (155522589)

Name	Address	ID/FEI	Business Operations
Establishment
Water-Jel Technologies		155522589	manufacture(59898-170)

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Medic