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Mineral Ice Pain Relieving

Dosage form: gel
Ingredients: MENTHOL, UNSPECIFIED FORM .02g in 1g
Labeler: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
NDC Code: 0067-2067

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.

Drug Facts

Active ingredient  

Menthol 2%

Purpose

Topical analgesic

Uses
temporarily relieves minor aches and pains of muscles and joints associated with:
o
arthritis
o
simple backache
o
strains
o
bruises
o
sprains
provides cooling penetrating relief

Warnings

For external use only

Do not use
with other topical pain relievers
with heating pads or heating devices

When using this product
do not use in or near the eyes
do not apply to wounds or damaged skin
do not bandage tightly

Stop use and ask a doctor if
condition worsens
symptoms last more than 7 days or clear up and occur again within a few days

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 right away.

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

Inactive ingredients

ammonium hydroxide, carbomer, cupric sulfate, FD&C blue no. 1, isopropyl alcohol, magnesium sulfate, purified water, sodium hydroxide, thymol

Questions or comments?

call 1-800-328-5258

Principal Display Panel

NDC 0067-2067-16

Mineral Ice®

ORIGINAL

THERAPEUTIC

MENTHOL PAIN RELIEVING GEL

Greaseless

With DEEPCOLD® Pain Reliever

Net Wt 16oz (453.6g)

Distributed by: GSK Consumer Healthcare

Warren, NJ 07059

©2016 GSK or its licensor.

Made in Canada

Trademarks are owned by or licensed to the GSK group of companies.

12904

MINERAL ICE  PAIN RELIEVING
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-2067
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (MENTHOL, UNSPECIFIED FORM) MENTHOL, UNSPECIFIED FORM.02 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
AMMONIA 
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) 
CUPRIC SULFATE 
FD&C BLUE NO. 1 
ISOPROPYL ALCOHOL 
MAGNESIUM SULFATE, UNSPECIFIED FORM 
WATER 
SODIUM HYDROXIDE 
THYMOL 
Packaging
#Item CodePackage Description
1NDC:0067-2067-3599.2 g in 1 JAR
2NDC:0067-2067-08226.8 g in 1 JAR
3NDC:0067-2067-16453.6 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/01/2011
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 02/2017
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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