BURN JEL PLUS- gel for burns gel 
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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Burn Jel Plus

Active ingredient

Lidocaine HCl 2.5%

Purpose

External analgesic

Uses

for the temporary relief of pain associated with minor burns

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

  • conditions worsens
  • symptoms persist for more than 7 days
  • condition clears up and occurs again within a few days

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Inactive ingredients

carbomer 940, carbomer 1342, diazolidinyl urea, edetate disodium, glycerin, methylparaben, octoxynol 9, propylene glycol, propylparaben, purified water, tea tree oil, trolamine, vitamin E acetate

Questions ?

1-800-275-3433 www.waterjel.com

Principal Display Panel

Burn Jel Plus

BURN JEL PLUS 
gel for burns gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59898-202
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS2.5 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 COPOLYMER TYPE B (UNII: 1G56KV7BUJ)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59898-202-101 in 1 CARTON04/10/2010
159 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:59898-202-1124 in 1 CARTON04/10/2010
259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC:59898-202-121 in 1 CARTON04/10/2010
3118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4NDC:59898-202-1324 in 1 CARTON04/10/2010
4118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/10/2010
Labeler - Water-Jel Technologies (155522589)
Registrant - Water-Jel Technologies (155522589)
Establishment
NameAddressID/FEIBusiness Operations
Water-Jel Technologies155522589manufacture(59898-202)

Revised: 12/2017
Document Id: 5f4b670a-63df-dfc4-e053-2991aa0a4b1c
Set id: 401023a5-6634-4c04-b6a6-55b78a9c79fe
Version: 3
Effective Time: 20171201
 
Water-Jel Technologies