MINERAL ICE PAIN RELIEVING- menthol gel

Mineral Ice by

Drug Labeling and Warnings

Mineral Ice by is a Otc medication manufactured, distributed, or labeled by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

MINERAL ICE  PAIN RELIEVING
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0067-2067
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	.02 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
AMMONIA (UNII: 5138Q19F1X)
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)
CUPRIC SULFATE (UNII: LRX7AJ16DT)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
THYMOL (UNII: 3J50XA376E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0067-2067-35	99.2 g in 1 JAR; Type 0: Not a Combination Product	11/01/2011	04/30/2020
2	NDC: 0067-2067-08	226.8 g in 1 JAR; Type 0: Not a Combination Product	11/01/2011	08/31/2020
3	NDC: 0067-2067-16	453.6 g in 1 JAR; Type 0: Not a Combination Product	11/01/2011	08/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	11/01/2011	08/31/2020

Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)