FDA.reportPublic FDA data

U ICE COLD

Manufacturer
Ningbo Liyuan Daily Chemical Products Co., Ltd.
Effective date
2018-08-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:50:11

Label at a glance#

ProductU ICE COLD
Active ingredientCAMPHOR, (-)-, MENTHOL
Label structure12 sections

Indications and uses

for the temporary relief of minor aches and pains in muscles and joints associated with: simple backache, strains, sprains, sports injuries, arthritis, bruises

Dosage and administration

clean affected area before applying products adults and children 2 years of age and older apply to affected area not more than 3 to 4 times daily

Label contents#

Full prescribing information#

Drug Facts Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Menthol 1 percent...............................................Topical Analgesic

Camphor 0.5 percent.........................................Topical Analgesic

OTC - PURPOSE SECTION

Topical Analgesic

Uses:

DOSAGE & ADMINISTRATION SECTION

for the temporary relief of minor aches and pains in muscles and joints associated with:

simple backache, strains, sprains, sports injuries, arthritis, bruises

Warnings: External Use Only

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

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 eyes
  • Do not apply to wounds or damaged skin
  • Do not bandage tightly

Stop use and ask 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 Posion Control Center immediately.

Directions

INDICATIONS & USAGE SECTION

  • clean affected area before applying products
  • adults and children 2 years of age and older
  • apply to affected area not more than 3 to 4 times daily

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Water(Aqua), Ethyl Alcohol, Carbomer, Methylchloroisothiazolinone, Methylisothiazolinone, Triethanolamine, FD&C Blue No. 1

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76176-04576176-045-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAMPHOR, (-)-213N3S8275ACTIB
FD&C BLUE NO. 1H3R47K3TBDIACT
TRIETHANOLAMINE BENZOATEM3EN4GC19WIACT
WATER059QF0KO0RIACT
METHYL ALCOHOLY4S76JWI15IACT
CARBOMER 934Z135WT9208IACT
MENTHOLL7T10EIP3AACTIB
METHYLISOTHIAZOLINONE229D0E1QFAIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT

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
760be0f2-b5b3-b22a-e053-2991aa0a90d5760be0f2-b5b2-b22a-e053-2991aa0a90d52018-08-01WarningsExact identifier
spl id: 760be0f2-b5b3-b22a-e053-2991aa0a90d5
spl set id: 760be0f2-b5b2-b22a-e053-2991aa0a90d5

Reported adverse events (FAERS/openFDA)#

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