Ice Power Pain Relieving Gel

Ice Power Pain Relieving by

Drug Labeling and Warnings

Ice Power Pain Relieving by is a Otc medication manufactured, distributed, or labeled by Fysioline Oy. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ICE POWER PAIN RELIEVING- menthol gel 
Fysioline Oy

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Ice Power Pain Relieving Gel

Drug Facts

Active ingredient

Menthol 3 %

Purpose

Pain Relief

Uses

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

Warnings

For external use only.

Flammable: Keep away from excessive heat or open flame.

Ask a doctor before use if you have:

Sensitive skin.

When using this product

  • 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

  • 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,

ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

  • 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

Wash your hands carefully after application with cool water.

Inactive ingredients

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

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

LabelLabel2

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

Label3Label4

ICE POWER PAIN RELIEVING 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 72708-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL30 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
ALCOHOL (UNII: 3K9958V90M)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 72708-001-901 in 1 BOX10/01/201910/02/2019
190 g in 1 TUBE; Type 0: Not a Combination Product
2NDC: 72708-001-151 in 1 BOX10/01/201910/02/2019
2150 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/01/201910/02/2019
Labeler - Fysioline Oy (540106952)

Revised: 6/2019
Document Id: 8bd9e9fa-bbb3-7f96-e053-2a95a90a9a4b
Set id: fcdf2a6a-06a3-474f-8f2e-458a08f74a03
Version: 2
Effective Time: 20190621
 
Fysioline Oy