Neutrogena

Basic Information

• Brand Name: Neutrogena
• Primary DI: 00070501101247
• Version / Model: 00070501101247
• Company Name: Johnson & Johnson Consumer Inc.
• Labeler DUNS: 118772437
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-30
• Public Version: 5
• Public Version Date: 2023-06-13
• Public Version Status: Update
• Public Device Record Key: b6053cff-a2ad-4de5-9b2c-f0240ad22587
• Distribution End Date: 2020-06-22

Device Description

Light Therapy Acne Mask

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OLP	Over-the-counter powered light based laser for acne	General, Plastic Surgery	878.4810	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62116	Red/blue light phototherapy unit	A portable electrically-powered device intended to emit both red and blue light for the treatment of a facial skin condition (e.g., acne, hyperpigmentation) by the patient in the home. It includes integral lights with a controller/controlling interface (to pair with an off-the-shelf computer/smartphone), and may be available in a variety of forms (e.g., a face-worn light mask with controller, hand-held light unit). It is not intended for use with a photosensitizing agent. This is a single-patient, reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00070501101247	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Atmospheric Pressure
• Temperature Range: .7 – 1.06 KiloPascal
• Type: Storage Environment Temperature
• Temperature Range: 5 – 25 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 0 – 60 Percent (%) Relative Humidity