FDA.reportPublic FDA data

Ice Power Pain Relieving Gel

Manufacturer
Fysioline Oy
Effective date
2019-06-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:09:21

Label at a glance#

ProductIce Power Pain Relieving
Active ingredientMENTHOL
Label structure8 sections

Indications and uses

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.

Dosage and administration

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: consult a physician.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 3 %

Purpose

OTC - PURPOSE SECTION

Pain Relief

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.

Warnings

WARNINGS SECTION

For external use only.

Flammable: Keep away from excessive heat or open flame.

Ask a doctor before use if you have:

OTC - ASK DOCTOR SECTION

Sensitive skin.

When using this product

OTC - WHEN USING SECTION

  • Avoid contact with eyes or mucous membranes.
  • Do not apply to wounds or damaged skin.
  • Do not bandage tightly.
  • Do not use with heating pads or device.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • Condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days.
  • Redness or excessive 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 immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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: consult a physician.

Other information

SPL UNCLASSIFIED SECTION

Wash your hands carefully after application with cool water.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Alcohol Denat, Glycerin, Purified Water, Sodium Hydroxide

Ice Power Pain Relieving Gel, 90g (72708-001-90) 

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabelLabel2Label2

Ice Power Pain Relieving Gel, 150g (72708-001-15)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label3Label3Label4Label4

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72708-00172708-001-90, 72708-001-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
ALCOHOL3K9958V90MIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
SODIUM HYDROXIDE55X04QC32IIACT
MENTHOLL7T10EIP3AACTIB

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
8bd9e9fa-bbb3-7f96-e053-2a95a90a9a4bfcdf2a6a-06a3-474f-8f2e-458a08f74a032019-06-21WarningsExact identifier
spl id: 8bd9e9fa-bbb3-7f96-e053-2a95a90a9a4b
spl set id: fcdf2a6a-06a3-474f-8f2e-458a08f74a03

Reported adverse events (FAERS/openFDA)#

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