FDA.reportPublic FDA data

Ice Power Pain Relieving Cream

Manufacturer
Fysioline Oy
Effective date
2019-06-24
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:09:16

Label at a glance#

ProductIce Power Pain Relieving
Active ingredientMENTHOL
Label structure7 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.

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.

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.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Cetyl Alcohol, Citric Acid, Ethylhexylglycerin, Glyceryl Stearate, PEG-100 Stearate, Phenoxyethanol, Propylene Glycol, Purified Water

Ice Power Pain Relieving Cream, 90g 72708-002-90

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label5Label5Label6Label6

Ice Power Pain Relieving Cream, 150g 72708-002-15

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label7Label7Label8Label8

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
72708-00272708-002-90, 72708-002-15

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
CETYL ALCOHOL936JST6JCNIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-100 STEARATEYD01N1999RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
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
8c13d6e5-4df7-44f7-e053-2a95a90a5ffc81dbecdf-d90d-449d-949c-e82e73c28ec42019-06-24WarningsExact identifier
spl id: 8c13d6e5-4df7-44f7-e053-2a95a90a5ffc
spl set id: 81dbecdf-d90d-449d-949c-e82e73c28ec4

Reported adverse events (FAERS/openFDA)#

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