NDC 68678-067

PROTEC ROLL-ON

Menthol

PROTEC ROLL-ON is a Topical Gel in the Human Otc Drug category. It is labeled and distributed by Ach Ventures Corp. The primary component is Menthol.

• Product ID: 68678-067_0d617965-6c3a-431f-b4f9-43df13744f95
• NDC: 68678-067
• Product Type: Human Otc Drug
• Proprietary Name: PROTEC ROLL-ON
• Generic Name: Menthol
• Dosage Form: Gel
• Route of Administration: TOPICAL
• Marketing Start Date: 2016-02-19
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part348
• Labeler Name: ACH VENTURES CORP
• Substance Name: MENTHOL
• Active Ingredient Strength: 8 g/100mL
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 68678-067-04

95 mL in 1 BOTTLE, DISPENSING (68678-067-04)

• Marketing Start Date: 2016-02-19
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68678-067-04 [68678006704]

PROTEC ROLL-ON GEL

• Marketing Category: OTC monograph not final
• Application Number: part348
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2016-02-19
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
MENTHOL	8 g/100mL

OpenFDA Data

• SPL SET ID: de81646b-748e-4cfd-93f1-a83abc91da42
• Manufacturer:
  • ACH VENTURES CORP
• UNII:
  • L7T10EIP3A
• RxNorm Concept Unique ID - RxCUI:
  • 283257

NDC Crossover Matching brand name "PROTEC ROLL-ON" or generic name "Menthol"

NDC	Brand Name	Generic Name
68678-067	PROTEC ROLL-ON	PROTEC ROLL-ON
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