NDC 0498-0203

Burn Jel

Gel For Burns

Burn Jel is a Topical Gel in the Human Otc Drug category. It is labeled and distributed by Honeywell Safety Products Usa, Inc. The primary component is Lidocaine Hydrochloride.

• Product ID: 0498-0203_7640e178-c198-c9d6-e053-2991aa0a2c5a
• NDC: 0498-0203
• Product Type: Human Otc Drug
• Proprietary Name: Burn Jel
• Generic Name: Gel For Burns
• Dosage Form: Gel
• Route of Administration: TOPICAL
• Marketing Start Date: 2018-09-19
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part348
• Labeler Name: Honeywell Safety Products USA, Inc
• Substance Name: LIDOCAINE HYDROCHLORIDE
• Active Ingredient Strength: 2 g/100g
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0498-0203-34

10 PACKET in 1 CARTON (0498-0203-34) > 3.5 g in 1 PACKET (0498-0203-00)

• Marketing Start Date: 2018-09-19
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0498-0203-34 [00498020334]

Burn Jel GEL

• Marketing Category: OTC monograph not final
• Application Number: part348
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2018-09-19

NDC 0498-0203-00 [00498020300]

Burn Jel GEL

• Marketing Category: OTC monograph not final
• Application Number: part348
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2018-09-19

Drug Details

Active Ingredients

Ingredient	Strength
LIDOCAINE HYDROCHLORIDE	2 g/100g

OpenFDA Data

• SPL SET ID: 5fdfe7d1-6dc7-57a6-e053-2991aa0ac9c1
• Manufacturer:
  • Honeywell Safety Products USA, Inc
• UNII:
  • V13007Z41A
• RxNorm Concept Unique ID - RxCUI:
  • 1011852
  • 2056934

NDC Crossover Matching brand name "Burn Jel" or generic name "Gel For Burns"

NDC	Brand Name	Generic Name
0498-0203	Burn Jel	Gel for Burns
59898-200	Burn Jel	Lidocaine Hydrochloride
59898-202	Burn Jel Plus	Gel for Burns