FDA.reportPublic FDA data

Mentholatum Kids Head Lice Removal Kit

Primary DI
00310742011234
Brand
Mentholatum Kids Head Lice Removal Kit
Company
MENTHOLATUM COMPANY, THE
Model
1123
Device description
One 3.38 FL OZ (100 mL) bottle with one lice comb.
Published
2021-07-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LJLDetectors And Removers, Lice, (Including Combs)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LJLDetectors And Removers, Lice, (Including Combs)General Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00310742011234PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00310742011234003107420112343107420112340310742011234

GMDN Terms#

Term, Definition table
TermDefinition
Lice treatment solution, syntheticA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-877-636-2677consumeraffairs@mentholatum.com

Regulatory Flags#

DUNS number
002105757
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00310742098426WellPatch(R) HEAT THERAPY PAIN RELIEF PATCH98422020-02-07
00310742015706WellPatch(R) MIGRAINE & HEADACHE Cooling Patch, 4 Count15702020-02-07
00310742015904Mentholatum(R) VaporDuo(TM)15902020-02-07
00310742915907Mentholatum(R) VaporDuo(TM)15902020-02-07
00310742998429WellPatch(R) HEAT THERAPY PAIN RELIEF PATCH98422020-02-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840117335301WeCare Metal Lice And Nit Removal Comb, Striped Teeth Dynarex CorporationLJL2024-03-21
00840117335295WeCare Metal Lice Comb With Handle Light Blue DYNAREX CORPORATIONLJL2024-03-21
00840117335288WeCare ClearNit Metal Lice and Nit Removal Comb, With HandleDynarex CorporationLJL2024-03-11
00840117335271WeCare Metal Lice Combs Blue DYNAREX CORPORATIONLJL2024-03-11
00057475211301BIOS LivingThermor LtdLJL2023-09-18
10057475211308BIOS LivingThermor LtdLJL2023-09-18
00663580000022LiceguardLiceguard, LLCLJL2023-08-18
00663580012025LiceguardLiceguard, LLCLJL2023-08-18
00810061048114RID Oystershell Consumer Health, IncLJL2022-09-23
00810061048138RID Oystershell Consumer Health, IncLJL2022-09-23
00810061048145RIDOystershell Consumer Health, IncLJL2022-09-23
00810061048268RID Oystershell Consumer Health, IncLJL2022-09-23
00810061048275RIDOystershell Consumer Health, IncLJL2022-09-23
00810061048282RIDOystershell Consumer Health, IncLJL2022-09-23
00311917192871WalgreensWALGREEN CO.LJL2020-11-27
00311917192888Lice Killing Shampoo 8 ozWALGREEN CO.LJL2020-11-27
00311917192895WalgreensWALGREEN CO.LJL2020-11-27
00079573000762Ezy DoseAPOTHECARY PRODUCTS, LLCLJL2020-10-28
20079573000766Ezy DoseAPOTHECARY PRODUCTS, LLCLJL2020-10-28
00079573009192Ezy DoseAPOTHECARY PRODUCTS, LLCLJL2020-10-16
00079573104910Ezy DoseAPOTHECARY PRODUCTS, LLCLJL2020-10-16
00079573105948Ezy DoseAPOTHECARY PRODUCTS, LLCLJL2020-10-16
00079573109168Ezy DoseAPOTHECARY PRODUCTS, LLCLJL2020-10-16
10079573009199Ezy DoseAPOTHECARY PRODUCTS, LLCLJL2020-10-16
10079573104917Ezy DoseAPOTHECARY PRODUCTS, LLCLJL2020-10-16
10079573105945Ezy DoseAPOTHECARY PRODUCTS, LLCLJL2020-10-16
10079573109165Ezy DoseAPOTHECARY PRODUCTS, LLCLJL2020-10-16
00050428359655CVS HEALTHWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDLJL2020-09-18
00079573108123Acu-Life (HE)APOTHECARY PRODUCTS, LLCLJL2020-09-11
00050428315576CVS HEALTHWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDLJL2020-07-29