Mentholatum Kids Head Lice Removal Kit

Basic Information

• Brand Name: Mentholatum Kids Head Lice Removal Kit
• Primary DI: 00310742011234
• Version / Model: 1123
• Company Name: MENTHOLATUM COMPANY, THE
• Labeler DUNS: 002105757
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-07-01
• Public Version: 1
• Public Version Date: 2021-07-09
• Public Version Status: New
• Public Device Record Key: 6c064ea9-bee9-4353-bf71-0a77ffd4e2d7

Device Description

One 3.38 FL OZ (100 mL) bottle with one lice comb.

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LJL	Detectors And Removers, Lice, (Including Combs)	General Hospital	880.5960	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46982	Lice treatment solution, synthetic	A non-sterile, liquid substance intended to be applied topically to the scalp and head hair to eradicate human head lice (Pediculus humanus capitis) through physical means. It contains synthetic compound agents (e.g., dimeticone, cyclomethicone, isopropyl myristate) that kill the lice through a non-poisonous action such as: 1) coating and encapsulating the lice preventing the excretion of water that will eventually smother them; or 2) coating them and causing them to dehydrate (loose water) and die; it may also penetrate the lice eggs in order to kill them. It does not include a lice comb. After application, this device cannot be reused.	No	Active
17552	Lice comb, manual	A hand-held manual device with specially-designed teeth (tines) spaced with precision and intended to be systematically drawn through the hair, typically following the contour of the scalp, to expose and remove human head lice (Pediculus humanus capitis) and their eggs (nits) from the hair and scalp of an infested person. It is normally available non-prescription and over-the-counter (OTC). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00310742011234	GS1

Customer Contacts

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