FDA.reportPublic FDA data

Freeze Away Wart Remover

Primary DI
20888853000101
Brand
Freeze Away Wart Remover
Company
SCHOLL'S WELLNESS COMPANY LLC
Model
90000335
Device description
Cryogenic wart remover
Published
2025-01-23
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
GEHUnit, Cryosurgical, Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEHUnit, Cryosurgical, AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K031697000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K031697000DR. SCHOLL'S FREEZE AWAY WART REMOVER, MODEL 40226Schering-Plough Healthcare Products, Inc.2003-08-29GEH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20888853000101PrimaryGS10
00888853000107Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088885300010120888853000101
00888853000107008888530001078888530001070888853000107

GMDN Terms#

Term, Definition table
TermDefinition
Wart-removal cryogenic kitA collection of devices designed to apply cold from a liquid/gaseous refrigerant (cryogen) to a common or plantar (sole of foot) wart for its removal. The collection typically includes a pressurized cannister with a cryogenic mixture (e.g., liquid dimethyl ether and propane), disposable applicators, a reusable activator that releases the cryogen into the applicators, and cushions; it may also include a liquid wart remover (e.g., salicylic acid) for post-cryo treatment. It is normally available [non-prescription] over-the-counter (OTC). This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature68 Degrees Fahrenheit77 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
18623281407alex.terranova@drscholls.com

Regulatory Flags#

DUNS number
117174744
Device count
8
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10888853000128Freeze Away Wart Remover900000722025-01-23
10888853004836Freeze Away Pinpoint Skin Tag Remover90000625900006252025-10-01
10888853004867Freeze Away Sub Zero Wart Remover90000619900006192025-09-10
10888853001330Freeze Away Dual Action Wart Remover900003362025-01-23
00888853003214Freeze Away Max Plantar Wart Remover900003842024-01-03
10888853003211Freeze Away Max Plantar Wart Remover900003842024-01-03
00888853000053Dr Scholls Freeze Away 7ct Yellow900000902021-01-06
00888853003467Freeze Away Skin Tag Remover900004152022-09-21
00888853000619Dr Scholls Freeze Away Max Wart Remover900000672021-02-03
00888853000084Dr Scholls Freeze Away Dual Action 7ct Blue900001202021-01-06
00888853000114Dr Scholls Freeze Away 7ct Blue900000702021-01-06
00888853000138Dr Scholls Freeze Away 12ct Blue900000722021-01-06
20888853003461Freeze Away Skin Tag Remover900004152022-09-21
10888853002955Freeze Away Dual Action 8ct900003362022-07-12
00888853002958Freeze Away Dual Action 8ct900003362022-07-12
10888853002962Freeze Away 8ct900003352022-07-11
10888853000050Dr Scholls Freeze Away 7ct Yellow900000902021-01-06
10888853000135Dr Scholls Freeze Away 12ct Blue900000722021-01-06
10888853000043Dr Scholls Wart Remover 7 CT Yellow900000712020-09-03
00888853000107Dr Scholls Freeze Away Wart Remover7 Ct Blue900000702020-09-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10840143902666cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902673cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902680cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902697cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902703cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902710cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902727cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902734cryoICE® SystemATRICURE, INC.GEH2026-05-27
30840143904343cryoICE® SystemATRICURE, INC.GEH2026-05-27
30840143912164AtriCure® cryoICE® BOXATRICURE, INC.GEH2026-05-27
04050147024694ErbeErbe Elektromedizin GmbHGEH2026-05-26
08800073100148TargetCool-eRecensMedical, Inc.GEH2026-05-14
06974083413115CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-23
06974083413122CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-23
06974083413313CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-23
06974083413320CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-23
06974083413337CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-23
06974083413412CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-23
06974083413528CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-23
06974083413221CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-22
06974083410718CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-01
06974083413214CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-01
06974083413511CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-01
06974083413818CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-01
00860009734814ArtemisEigen Health Services LLCGEH2026-01-28
00860009734821Artemis-TPOSEigen Health Services LLCGEH2026-01-28
00194346615124EquateWAL-MART STORES, INC.GEH2025-12-22
10888853004836Freeze Away Pinpoint Skin Tag RemoverSCHOLL'S WELLNESS COMPANY LLCGEH2025-10-01
10888853004867Freeze Away Sub Zero Wart RemoverSCHOLL'S WELLNESS COMPANY LLCGEH2025-09-10
06935650602042HYGEAHygea Medical Technology Co., Ltd.GEH2025-09-08