U ICE COLD

Manufacturer
UNIVERSAL DISTRIBUTION CENTER LLC
Effective date
2023-09-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:56:32

Label at a glance#

ProductU ICE COLD
Active ingredientCAMPHOR, (-)-, MENTHOL
Label structure11 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

Purpose

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2056456camphor 0.5 % / menthol 1 % Topical OintmentPSN2
2056456camphor 0.005 MG/MG / menthol 0.01 MG/MG Topical OintmentSCD2
2056456camphor 0.5 % / menthol 1 % Topical OintmentSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52000-045-01U ICE COLD227 g in 1 TUBEOINTMENT2272

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52000-045U ICE COLD (MENTHOL) OINTMENT [UNIVERSAL DISTRIBUTION CENTER LLC]2Current NDC, Legacy NDC, 1 package rows20231008_752ef0cd-f12a-3b9e-e053-2991aa0abeb1.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52000-04552000-045-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

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
U ICE COLDMENTHOLUNIVERSAL DISTRIBUTION CENTER LLC752ef0cd-f12a-3b9e-e053-2991aa0abeb12023-09-01WarningsExact identifier
ndc (package): 52000-045-01
ndc (product): 52000-045
ndc11 (package): 52000004501
spl id: 0718e1be-e778-00f3-e063-6394a90a114e
spl set id: 752ef0cd-f12a-3b9e-e053-2991aa0abeb1

Reported adverse events (FAERS/openFDA)#

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