NDC 50382-022

Burn

Lidocaine Hydrochloride And Benzalkonium Chloride

Burn is a Topical Cream in the Human Otc Drug category. It is labeled and distributed by Galentic Pharma (india) Private Limited. The primary component is Lidocaine Hydrochloride; Benzalkonium Chloride.

• Product ID: 50382-022_3aed9595-6b39-4f79-8954-897501645126
• NDC: 50382-022
• Product Type: Human Otc Drug
• Proprietary Name: Burn
• Generic Name: Lidocaine Hydrochloride And Benzalkonium Chloride
• Dosage Form: Cream
• Route of Administration: TOPICAL
• Marketing Start Date: 2015-09-01
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part348
• Labeler Name: Galentic Pharma (India) Private Limited
• Substance Name: LIDOCAINE HYDROCHLORIDE; BENZALKONIUM CHLORIDE
• Active Ingredient Strength: 5 mg/g; mg/g
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 50382-022-11

10 PACKET in 1 CARTON (50382-022-11) > .9 g in 1 PACKET

• Marketing Start Date: 2016-04-14
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50382-022-12 [50382002212]

Burn CREAM

• Marketing Category: OTC monograph not final
• Application Number: part348
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2016-04-14

NDC 50382-022-13 [50382002213]

Burn CREAM

• Marketing Category: OTC monograph not final
• Application Number: part348
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2015-09-01

NDC 50382-022-11 [50382002211]

Burn CREAM

• Marketing Category: OTC monograph not final
• Application Number: part348
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2016-04-14

Drug Details

Active Ingredients

Ingredient	Strength
LIDOCAINE HYDROCHLORIDE	5 mg/g

OpenFDA Data

• SPL SET ID: 9abedfe3-52fa-44f5-b489-5c42b80c9348
• Manufacturer:
  • Galentic Pharma (India) Private Limited
• UNII:
  • F5UM2KM3W7
  • V13007Z41A
• RxNorm Concept Unique ID - RxCUI:
  • 1012100

NDC Crossover Matching brand name "Burn" or generic name "Lidocaine Hydrochloride And Benzalkonium Chloride"

NDC	Brand Name	Generic Name
0924-0930	Burn	Lidocaine Hydrochloride
43473-048	Burn	LIDOCAINE HYDROCHLORIDE
50382-020	Burn	Lidocaine Hydrochloride
50382-022	Burn	Lidocaine Hydrochloride and Benzalkonium Chloride
58301-181	Burn	Aesculus hippocastanum, Aloe socotrina, Arnica montana, Berberis vulgaris, Calendula officinalis, Salicylicum acidum, Zincum metallicum
62985-5082	Burn	Lidocaine Hydrochloride
73598-0671	Burn	lidocaine hydrochloride
82942-1001	Burn	LIDOCAINE HYDROCHLORIDE
68229-300	Alocane Plus	Lidocaine Hydrochloride and Benzalkonium Chloride
68229-404	Alocane Plus	Lidocaine Hydrochloride and Benzalkonium Chloride
0924-5011	First Aid Only First Aid/Burn	Lidocaine Hydrochloride and Benzalkonium Chloride