FDA.reportPublic FDA data

UNIVERSAL ICE COLD ANALGESIC GEL

Manufacturer
Universal Distribution Center LLC
Effective date
2023-11-15
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:02:35

Label at a glance#

ProductUniversal Ice Cold Analgesic
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure12 sections

Indications and uses

Temporary relieves  of minor aches and pains in 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 children under 2 years of age: ask a doctor

Storage and handling

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

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 1.25%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

Temporary relieves  of minor aches and pains in 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 doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms last more than 7 days or clean 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 the 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
  • children under 2 years of age: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • store at controlled room temperature 20 to 25oC (68 to 77oF in a tightly closed container
  • do not use, pour, spill or store near heat or open flame

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Propylene glycol, Isopropyl alcohol, Carbomer, Sodium hydroxide, Benzyl alcohol, Edetate Disodium, Butylated hydroxytoluene, Camphor, Fd&c Blue No. 1

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ICE COLD
ANALGESIC GEL
8 FL.OZ (227 GRAM)
PRINCIPAL DISPLAY PANELPRINCIPAL DISPLAY PANEL


DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
866128menthol 1.25 % Topical GelPSN3
866128menthol 0.0125 MG/MG Topical GelSCD3
866128menthol 1.25 % Topical GelSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52000-105-01Universal Ice Cold Analgesic227 g in 1 BOTTLE, PLASTICGEL2273

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52000-105UNIVERSAL ICE COLD ANALGESIC (MENTHOL) GEL [UNIVERSAL DISTRIBUTION CENTER LLC]3Current NDC, Legacy NDC, 1 package rows20231122_4fdf61d8-a9e0-4cd2-9e3f-0bdedc47a52f.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
52000-10552000-105-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
CAMPHOR (SYNTHETIC)5TJD82A1ETIACT
BENZYL ALCOHOLLKG8494WBHIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
EDETATE DISODIUM7FLD91C86KIACT
ISOPROPYL ALCOHOLND2M416302IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM HYDROXIDE55X04QC32IIACT
WATER059QF0KO0RIACT

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
Universal Ice Cold AnalgesicMENTHOLUniversal Distribution Center LLC4fdf61d8-a9e0-4cd2-9e3f-0bdedc47a52f2023-11-15WarningsExact identifier
ndc (package): 52000-105-01
ndc (product): 52000-105
ndc11 (package): 52000010501
spl id: 58b2217d-5ab4-4db5-8b59-cac4a647b414
spl set id: 4fdf61d8-a9e0-4cd2-9e3f-0bdedc47a52f

Reported adverse events (FAERS/openFDA)#

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