IWK-5- lidocaine hydrochloride 
Water-Jel Technologies

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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IWK-5

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

Other information

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

MEDICAL DEVICES 
 1 12" X 16" Face Mask
 1 8" x 18" Burn Dressing
 24" x 4" Burn Dressings
 1 4" x 16" Burn Dressing
 1 2" x 2.2 yd Elastic Bandage

 

Principal Display Panel

image of PDP

Principal Display Panel Packet

Principal Display Panel

IWK-5 
lidocaine hydrochloride kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59898-180
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59898-180-441 in 1 KIT06/12/2014
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 125 PACKET 87.5 mL
Part 1 of 1
BURN JEL 
lidocaine hydrochloride gel
Product Information
Item Code (Source)NDC:59898-200
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59898-200-1525 in 1 CARTON
1NDC:59898-200-353.5 mL in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/12/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/12/2014
Labeler - Water-Jel Technologies (155522589)
Establishment
NameAddressID/FEIBusiness Operations
Water-Jel Technologies155522589manufacture(59898-180)

Revised: 12/2017
Document Id: 5fc11494-a75c-7010-e053-2a91aa0afd34
Set id: f291841e-ccbd-4f5a-b1de-4cf596a167e3
Version: 8
Effective Time: 20171207
 
Water-Jel Technologies