FDA.reportPublic FDA data

PERSONAL CARE ICE COLD

Manufacturer
NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD.
Effective date
2024-01-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:13:05

Label at a glance#

ProductPERSONAL CARE ICE COLD
Active ingredientMENTHOL
Label structure12 sections

Indications and uses

temporarily relieves minor muscle aches and pains of muscles and joints associated with: arthritis, simple backache, strains, bruises, sports injuries, sprains, provides cooling penetrating relief

Dosage and administration

clean affected area before applying product. adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily. chidlren under 2 years of age: ask a doctor.

Storage and handling

store at controlled room temperature 20 to 25℃ (68 to 77°F) in a tightly closed container. do not use, pour, spill or store near heat or open flame.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 1.25%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves minor muscle aches and pains of muscles and joints associated with:

arthritis, simple backache, strains, bruises, sports injuries, sprains, provides cooling penetrating relief

Warnings

WARNINGS SECTION

For external use only.

Do not use: with other topical pain relievers, with heating pads or heating devices.

When using this product

OTC - WHEN USING SECTION

do not use in or near the eyes.

do not apply to wounds or damaged skin.

do not bandage tightly.

Stop use and ask a doctor if

OTC - STOP USE SECTION

condition worsens, symptoms last more than 7 days or clear up and occur again within a few days, redness or irritation develops.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

clean affected area before applying product.

adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.

chidlren under 2 years of age: ask a doctor.

Other information

STORAGE AND HANDLING SECTION

store at controlled room temperature 20 to 25℃ (68 to 77°F) in a tightly closed container.

do not use, pour, spill or store near heat or open flame.

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzyl alcohol, BHT, camphor, carbopol, disodium EDTA, FD&C blue no.1, isopropyl alcohol, PEG-40 hydrogenated castor oil, propylene glycol, sodium hydroxide, water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
866128menthol 1.25 % Topical GelPSN1
866128menthol 0.0125 MG/MG Topical GelSCD1
866128menthol 1.25 % Topical GelSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76176-021-01PERSONAL CARE ICE COLD227 g in 1 BOTTLE, PLASTICGEL2271

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76176-021PERSONAL CARE ICE COLD (MENTHOL) GEL [NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD.]1Current NDC, 1 package rows20240531_1994356c-e347-5b7d-e063-6394a90a476c.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76176-02176176-021-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM HYDROXIDE55X04QC32IIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
HYDROGENATED CASTOR OILZF94AP8MEYIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
WATER059QF0KO0RIACT
MENTHOLL7T10EIP3AACTIB
FD&C BLUE NO. 1H3R47K3TBDIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETIACT
BENZYL ALCOHOLLKG8494WBHIACT
EDETATE DISODIUM7FLD91C86KIACT
CARBOMER 934Z135WT9208IACT
ISOPROPYL ALCOHOLND2M416302IACT

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
PERSONAL CARE ICE COLDMENTHOLNINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD.1994356c-e347-5b7d-e063-6394a90a476c2024-01-01WarningsExact identifier
ndc (package): 76176-021-01
ndc (product): 76176-021
ndc11 (package): 76176002101
spl id: 19945420-4d52-3475-e063-6294a90a0ead
spl set id: 1994356c-e347-5b7d-e063-6394a90a476c

Reported adverse events (FAERS/openFDA)#

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