NDC 61566-117

Burn Relief Extra Strength Kool-Down

Lidocaine - 3.9%

Burn Relief Extra Strength Kool-Down is a Topical Cream in the Human Otc Drug category. It is labeled and distributed by Kool-down Inc. The primary component is Lidocaine.

• Product ID: 61566-117_7f9a4b20-4614-3b00-e053-2a91aa0a0658
• NDC: 61566-117
• Product Type: Human Otc Drug
• Proprietary Name: Burn Relief Extra Strength Kool-Down
• Generic Name: Lidocaine - 3.9%
• Dosage Form: Cream
• Route of Administration: TOPICAL
• Marketing Start Date: 2013-04-15
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part348
• Labeler Name: Kool-Down Inc
• Substance Name: LIDOCAINE
• Active Ingredient Strength: 4 g/100g
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 61566-117-04

113 g in 1 BOTTLE (61566-117-04)

• Marketing Start Date: 2013-04-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 61566-117-04 [61566011704]

Burn Relief Extra Strength Kool-Down CREAM

• Marketing Category: OTC monograph not final
• Application Number: part348
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2013-04-15

Drug Details

Active Ingredients

Ingredient	Strength
LIDOCAINE	3.9 g/100g

OpenFDA Data

• SPL SET ID: 7f991c90-b505-445c-e053-2991aa0a99c7
• Manufacturer:
  • Kool-Down Inc
• UNII:
  • 98PI200987
• RxNorm Concept Unique ID - RxCUI:
  • 2108915
  • 2108920
• UPC Code:
  • 0043399563480

NDC Crossover Matching brand name "Burn Relief Extra Strength Kool-Down" or generic name "Lidocaine - 3.9%"

NDC	Brand Name	Generic Name
61566-117	Burn Relief Extra Strength	Lidocaine - 3.9%
61566-279	Burn Relief Extra Strength	Lidocaine - 3.9%