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FSK-5

Medically reviewed on December 7, 2017

Dosage form: kit
Ingredients: LIDOCAINE HYDROCHLORIDE 2g in 100mL
Labeler: Water-Jel Technologies
NDC Code: 59898-170

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.

FSK-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
  • 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

MEDICAL DEVICES 
 2 2" x 6" Burn Dressings
 2 4" x 4" Burn Dressings
 112" x 16" Face Mask
 1 2" x 2.2 yd Elastic Bandage

 

Principal Display Panel

Principal Display Panel Packet

FSK-5 
lidocaine hydrochloride kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59898-170
Packaging
#Item CodePackage Description
1NDC:59898-170-431 KIT in 1 KIT
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 AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE ANHYDROUS2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE C 
GLYCERIN 
PROPYLENE GLYCOL 
METHYLPARABEN 
TEA TREE OIL 
DIAZOLIDINYL UREA 
TROLAMINE 
OCTOXYNOL-9 
CARBOMER HOMOPOLYMER TYPE B 
PROPYLPARABEN 
EDETATE DISODIUM 
Packaging
#Item CodePackage Description
1NDC:59898-200-1525 PACKET in 1 CARTON
1NDC:59898-200-353.5 mL in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/11/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/11/2014
Labeler - Water-Jel Technologies (155522589)
Establishment
NameAddressID/FEIOperations
Water-Jel Technologies155522589manufacture(59898-170)

 
Water-Jel Technologies

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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