NDC 66428-007

Instant Cool Skin Instant Relief. Sudden Results

Lidocaine 0.5%

Instant Cool Skin Instant Relief. Sudden Results is a Topical Lotion in the Human Otc Drug category. It is labeled and distributed by Therapon Skin Health, Lp. The primary component is Lidocaine.

• Product ID: 66428-007_336c1092-5c08-4801-8a98-5a3d69a65e84
• NDC: 66428-007
• Product Type: Human Otc Drug
• Proprietary Name: Instant Cool Skin Instant Relief. Sudden Results
• Generic Name: Lidocaine 0.5%
• Dosage Form: Lotion
• Route of Administration: TOPICAL
• Marketing Start Date: 2015-06-15
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part348
• Labeler Name: Therapon Skin Health, LP
• Substance Name: LIDOCAINE
• Active Ingredient Strength: 1 g/100mL
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 66428-007-01

60 mL in 1 BOTTLE (66428-007-01)

• Marketing Start Date: 2015-06-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 66428-007-01 [66428000701]

Instant Cool Skin Instant Relief. Sudden Results LOTION

• Marketing Category: OTC monograph not final
• Application Number: part348
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2015-06-15
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
LIDOCAINE	.5 g/100mL

OpenFDA Data

• SPL SET ID: 98e0673f-00e8-4eb0-a1d1-78baae6b6c7b
• Manufacturer:
  • Therapon Skin Health, LP
• UNII:
  • 98PI200987
• RxNorm Concept Unique ID - RxCUI:
  • 251919

NDC Crossover Matching brand name "Instant Cool Skin Instant Relief. Sudden Results" or generic name "Lidocaine 0.5%"

NDC	Brand Name	Generic Name
55316-777	Aloe Burn Relief	Lidocaine 0.5%
63868-784	Burn Relief	Lidocaine 0.5%
64048-5115	Burn Relief	Lidocaine 0.5%
0363-3107	Burn Relief Pain Reliever	Lidocaine 0.5%
41250-540	Burn ReliefRelief	Lidocaine 0.5%
55910-782	Burn ReliefRelief	Lidocaine 0.5%
11822-7800	First Aid Burn Relief	Lidocaine 0.5%
41520-348	Instant Burn Relief	Lidocaine 0.5%
66428-007	Instant Cool Skin	Lidocaine 0.5%
79481-2183	Meijer Burn Relief	Lidocaine 0.5%
36800-721	Sunburn Relief	Lidocaine 0.5%
59450-778	Sunburn Relief	Lidocaine 0.5%