NDC 69379-038

Rotex

Rotex Pain Relieving Cream

Rotex is a Topical Cream in the Human Otc Drug category. It is labeled and distributed by Home Aide Diagnostics, Inc.. The primary component is Methyl Salicylate; Menthol; Capsaicin.

• Product ID: 69379-038_1c834710-1287-3266-e054-00144ff8d46c
• NDC: 69379-038
• Product Type: Human Otc Drug
• Proprietary Name: Rotex
• Generic Name: Rotex Pain Relieving Cream
• Dosage Form: Cream
• Route of Administration: TOPICAL
• Marketing Start Date: 2015-08-10
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part348
• Labeler Name: Home Aide Diagnostics, Inc.
• Substance Name: METHYL SALICYLATE; MENTHOL; CAPSAICIN
• Active Ingredient Strength: 35 g/100g; g/100g; g/100g
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 69379-038-01

120 g in 1 BOTTLE, PLASTIC (69379-038-01)

• Marketing Start Date: 2015-08-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69379-038-01 [69379003801]

Rotex CREAM

• Marketing Category: OTC monograph not final
• Application Number: part348
• Product Type: HUMAN OTC DRUG
• Billing Unit: GM
• Marketing Start Date: 2015-08-10
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
METHYL SALICYLATE	35 g/100g

OpenFDA Data

• SPL SET ID: 1c834710-1286-3266-e054-00144ff8d46c
• Manufacturer:
  • Home Aide Diagnostics, Inc.
• UNII:
  • S07O44R1ZM
  • L7T10EIP3A
  • LAV5U5022Y
• RxNorm Concept Unique ID - RxCUI:
  • 1660761
• UPC Code:
  • 0169379038011