NDC 70585-111

PROZERO

Menthol

PROZERO is a Topical Gel in the Human Otc Drug category. It is labeled and distributed by Rlabs, Llc. The primary component is Menthol.

• Product ID: 70585-111_7e9f41bc-f38d-4c1a-baad-b06883188ef0
• NDC: 70585-111
• Product Type: Human Otc Drug
• Proprietary Name: PROZERO
• Generic Name: Menthol
• Dosage Form: Gel
• Route of Administration: TOPICAL
• Marketing Start Date: 2016-08-09
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part348
• Labeler Name: RLABS, LLC
• Substance Name: MENTHOL
• Active Ingredient Strength: 5 g/100mL
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 70585-111-05

5 mL in 1 TUBE (70585-111-05)

• Marketing Start Date: 2016-08-09
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70585-111-05 [70585011105]

PROZERO GEL

• Marketing Category: OTC monograph not final
• Application Number: part348
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2016-08-09

NDC 70585-111-34 [70585011134]

PROZERO GEL

• Marketing Category: OTC monograph not final
• Application Number: part348
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2016-08-09

Drug Details

Active Ingredients

Ingredient	Strength
MENTHOL	5 g/100mL

OpenFDA Data

• SPL SET ID: 09025c0a-1214-41bf-acde-2695834da52a
• Manufacturer:
  • RLABS, LLC
• UNII:
  • L7T10EIP3A
• RxNorm Concept Unique ID - RxCUI:
  • 415975
• UPC Code:
  • 0856231006003

NDC Crossover Matching brand name "PROZERO" or generic name "Menthol"

NDC	Brand Name	Generic Name
70585-111	PROZERO	PROZERO
0363-1071	Cherry Cough Drop	Menthol
0363-1086	Cherry Cough Drops	Menthol
0363-0150	Cool n Heat Patch for Arm, Neck and Leg	Menthol
0363-0152	Cool n Heat Patch for Back	Menthol
0363-1072	Honey Lemon Cough Drop	Menthol
0363-1087	Honey Lemon Cough Drop	Menthol
0219-0203	Humphreys Bendito Alcoholado	menthol
0363-1070	Menthol Cough Drop	menthol
0363-1084	Menthol Cough Drop	menthol
0067-2067	Mineral Ice	Menthol
0316-0226	Mineral Ice	Menthol
0316-0290	Mineral Ice Quick Dry Foam	Menthol
0363-0151	Pain Relieving Patch	Menthol
0363-1077	SF Honey Lemon Cough Drop	Menthol
0363-1085	SF Menthol Cough Drop	Menthol
0363-0043	Studio 35 Medicated Body	Menthol
0363-0864	Walgreens Cold Pain Relief	MENTHOL
0363-0874	Walgreens Cold Pain Relief	MENTHOL
0363-0966	Walgreens Sunburn Relief	Menthol