FDA.reportPublic FDA data

FREEZE COOLING PAIN RELIEF

Manufacturer
Shandong Vianor Healthy Science Co.,Ltd.
Effective date
2021-01-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:37:19

Label at a glance#

ProductFREEZE COOLING PAIN RELIEF
Active ingredientMENTHOL
Label structure10 sections

Dosage and administration

Adults and children 12 years and older: Apply a small amount to the affected area and massage gently, no more han 4 times per day. Wash hands with cool water after use.

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Menthol 4%

Purpose

OTC - PURPOSE SECTION

/

Use

INDICATIONS & USAGE SECTION

Adults and children 12 years and older: Apply a small amount to the affected area and massage gently, no more han 4 times per day. Wash hands with cool water after use.

Warnings

WARNINGS SECTION

for external use only.
In cose of Ingestion seek medical assistance.
If a rash appears, dis.continue use.

Do not use

OTC - DO NOT USE SECTION

If you are allerglc to any of the ingredients, on inflamed or broken skin around the eyes with other topical treatments under bandages or occlusive dressings on children under the age of 12

OTC - WHEN USING SECTION

If you are allerglc to any of the ingredients, on inflamed or broken skin around the eyes with other topical treatments under bandages or occlusive dressings on children under the age of 12

OTC - STOP USE SECTION

Consult your doctor or pharmacist before use if you are diabetic, pregnant or breastfeeding. have poor circulation, a skin condition or if symptoms persists.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years and older: Apply a small amount to the affected area and massage gently, no more han 4 times per day. Wash hands with cool water after use.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Alcohol Denat., Polysorbate-20, Glycerin, Propylene Glycol, Triethanolamine, Phenoxyethanol, Acrylates/ C10-30 Alkyl Acrylate Crosspolymer. Cinnamomum Camphora (Camphor) bark oil, Ethylhexylglycerin, limonene, Linalool, Cl42090 (FD&C Blue 1), CL17200 (D&C Red 33).

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

69980-102-05 200ml

69980-102-05 200ml69980-102-05 200ml

69980-102-04 150ml69980-102-04 150ml69980-102-04 150ml

69980-102-02 50ml

69980-102-02 50ml69980-102-02 50ml

69980-102-01 30ml 69980-102-01 30ml69980-102-01 30ml

69980-102-03 100ml 69980-102-03 100ml69980-102-03 100ml

69980-102-06 30ml

69980-102-06 30ml69980-102-06 30ml

69980-102-07 50ml

69980-102-07 50ml69980-102-07 50ml

69980-102-08 100ml

69980-102-08 100ml69980-102-08 100ml

69980-102-09 150ml

69980-102-09 150ml69980-102-09 150ml

69980-102-010 200ml

69980-102-010 200ml69980-102-010 200ml

69980-102-011 227ml

69980-102-011 227ml69980-102-011 227ml

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
415974menthol 4 % Topical GelPSN2
415974menthol 0.04 MG/MG Topical GelSCD2
415974menthol 4 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69980-102-012022-07-29C16284748780-1e4f33bdf-a488-d8a0-e053-dadaa90a6e4e69980-102 FREEZE COOLING PAIN RELIEF
69980-102-022022-07-29C16284748780-1e4f33bdf-a488-d8a0-e053-dadaa90a6e4e69980-102 FREEZE COOLING PAIN RELIEF
69980-102-032022-07-29C16284748780-1e4f33bdf-a488-d8a0-e053-dadaa90a6e4e69980-102 FREEZE COOLING PAIN RELIEF
69980-102-042022-07-29C16284748780-1e4f33bdf-a488-d8a0-e053-dadaa90a6e4e69980-102 FREEZE COOLING PAIN RELIEF
69980-102-052022-07-29C16284748780-1e4f33bdf-a488-d8a0-e053-dadaa90a6e4e69980-102 FREEZE COOLING PAIN RELIEF
69980-102-062022-07-29C16284748780-1e4f33bdf-a488-d8a0-e053-dadaa90a6e4e69980-102 FREEZE COOLING PAIN RELIEF
69980-102-072022-07-29C16284748780-1e4f33bdf-a488-d8a0-e053-dadaa90a6e4e69980-102 FREEZE COOLING PAIN RELIEF
69980-102-082022-07-29C16284748780-1e4f33bdf-a488-d8a0-e053-dadaa90a6e4e69980-102 FREEZE COOLING PAIN RELIEF
69980-102-092022-07-29C16284748780-1e4f33bdf-a488-d8a0-e053-dadaa90a6e4e69980-102 FREEZE COOLING PAIN RELIEF
69980-102-102022-07-29C16284748780-1e4f33bdf-a488-d8a0-e053-dadaa90a6e4e69980-102 FREEZE COOLING PAIN RELIEF
69980-102-112022-07-29C16284748780-1e4f33bdf-a488-d8a0-e053-dadaa90a6e4e69980-102 FREEZE COOLING PAIN RELIEF

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69980-102-01FREEZE COOLING PAIN RELIEF30 mL in 1 BOTTLEGEL302
69980-102-02FREEZE COOLING PAIN RELIEF50 mL in 1 BOTTLEGEL502
69980-102-03FREEZE COOLING PAIN RELIEF100 mL in 1 BOTTLEGEL1002
69980-102-04FREEZE COOLING PAIN RELIEF150 mL in 1 BOTTLEGEL1502
69980-102-05FREEZE COOLING PAIN RELIEF200 mL in 1 BOTTLEGEL2002
69980-102-06FREEZE COOLING PAIN RELIEF30 mL in 1 BOTTLEGEL302
69980-102-07FREEZE COOLING PAIN RELIEF50 mL in 1 BOTTLEGEL502
69980-102-08FREEZE COOLING PAIN RELIEF100 mL in 1 BOTTLEGEL1002
69980-102-09FREEZE COOLING PAIN RELIEF150 mL in 1 BOTTLEGEL1502
69980-102-10FREEZE COOLING PAIN RELIEF200 mL in 1 BOTTLEGEL2002
69980-102-11FREEZE COOLING PAIN RELIEF227 mL in 1 BOTTLEGEL2272

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69980-102FREEZE COOLING PAIN RELIEF GEL [SHANDONG VIANOR HEALTHY SCIENCE CO.,LTD.]2Legacy NDC, 11 package rows20210127_ad967560-7bce-fd6a-e053-2a95a90a7dca.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69980-10269980-102-01, 69980-102-02, 69980-102-03, 69980-102-04, 69980-102-05, 69980-102-06, 69980-102-07, 69980-102-08, 69980-102-09, 69980-102-10, 69980-102-11

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER INTERPOLYMER TYPE A (55000 CPS)59TL3WG5COIACT
LINALOOL, (+/-)-D81QY6I88EIACT
D&C RED NO. 339DBA0SBB0LIACT
ALCOHOL3K9958V90MIACT
POLYSORBATE 207T1F30V5YHIACT
WATER059QF0KO0RIACT
MENTHOLL7T10EIP3AACTIB
GLYCERINPDC6A3C0OXIACT
CAMPHOR OIL75IZZ8Y727IACT
LIMONENE, (+)-GFD7C86Q1WIACT
TROLAMINE9O3K93S3TKIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PHENOXYETHANOLHIE492ZZ3TIACT
FD&C BLUE NO. 1H3R47K3TBDIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b9c612ef-bd1a-d1e2-e053-2995a90a3af7ad967560-7bce-fd6a-e053-2a95a90a7dca2021-01-25WarningsExact identifier
spl id: b9c612ef-bd1a-d1e2-e053-2995a90a3af7
spl set id: ad967560-7bce-fd6a-e053-2a95a90a7dca

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.