EBSL-5- lidocaine hydrochloride kit

EBSL-5 by

Drug Labeling and Warnings

EBSL-5 by is a Otc medication manufactured, distributed, or labeled by Water-Jel Technologies. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• 2: 4" x 4" Burn Dressing
• 2: 4" x 16" Burn Dressing
• 1: 8" x 18" Burn Dressing
• 1: 12" x 16" Face Mask
• 2: 3" Rolls of Gauze
• 1: Pair of Scissors

 

Principal Display Panel

Principal Display Panel Packet

Principal Display Panel

INGREDIENTS AND APPEARANCE

EBSL-5 
lidocaine hydrochloride kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59898-140

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59898-140-40	1 in 1 KIT; Type 0: Not a Combination Product	06/11/2014

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	10 PACKET	35 mL
Part 2	1 BOTTLE, PLASTIC	59 mL

Part 1 of 2

BURN JEL 
lidocaine hydrochloride gel

Product Information
Item Code (Source)	NDC: 59898-200
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59898-200-49	10 in 1 BOX
1	NDC: 59898-200-35	3.5 mL in 1 PACKET; 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	06/11/2014

Part 2 of 2

BURN JEL 
lidocaine hydrochloride gel

Product Information
Item Code (Source)	NDC: 59898-200
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59898-200-10	59 mL in 1 BOTTLE, PLASTIC; 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	06/11/2014

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

Labeler - Water-Jel Technologies (155522589)

Establishment
Name	Address	ID/FEI	Business Operations
Water-Jel Technologies		155522589	manufacture(59898-140)