Label: BURN JEL PLUS- gel for burns gel
- NDC Code(s): 59898-202-10, 59898-202-11, 59898-202-12, 59898-202-13
- Packager: Water-Jel Technologies
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated December 1, 2017
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INGREDIENTS AND APPEARANCE
BURN JEL PLUS
gel for burns gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59898-202 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 2.5 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 COPOLYMER TYPE B (UNII: 1G56KV7BUJ) EDETATE DISODIUM (UNII: 7FLD91C86K) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59898-202-10 1 in 1 CARTON 04/10/2010 1 59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:59898-202-11 24 in 1 CARTON 04/10/2010 2 59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 3 NDC:59898-202-12 1 in 1 CARTON 04/10/2010 3 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 4 NDC:59898-202-13 24 in 1 CARTON 04/10/2010 4 118 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 04/10/2010 Labeler - Water-Jel Technologies (155522589) Registrant - Water-Jel Technologies (155522589) Establishment Name Address ID/FEI Business Operations Water-Jel Technologies 155522589 manufacture(59898-202)