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 Crown Laboratories. 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:

● arthritis ● simple backache ● strains

• ● bruises ● 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 20 o - 25 oC (68 o - 77 oF) [see USP Controlled Room Temperature], 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 1-833-279-6522

Additional Information Listed on Other Panels

Distributed by: Crown Laboratories, Inc.

Johnson City, TN 37604 ©2018 Made in Canada.

ORIGINAL THERAPEUTIC

Mineral Ice ®

Menthol Pain Relieving Gel

Greaseless with DEEPCOLD ® Pain Reliever

Mineral Ice and the Mineral Ice Mountain range are registered trademarks of Crown Laboratories, Inc.

Principal Display

0316-0226-08

Mineral Ice®

Menthol Pain Relieving Gel

Greaseless with DEEPCOLD® Pain Reliever

Net wt. 8 oz (226.8 g)

Distributed by: Crown Laboratories, Inc.

Johnson City, TN 37604

p11529.00

INGREDIENTS AND APPEARANCE

MINERAL ICE  PAIN RELIEVING
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0316-0226
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	20 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
AMMONIA (UNII: 5138Q19F1X)
CARBOMER HOMOPOLYMER TYPE B (UNII: HHT01ZNK31)
CUPRIC SULFATE (UNII: LRX7AJ16DT)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
THYMOL (UNII: 3J50XA376E)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0316-0226-35	99.2 g in 1 JAR; Type 0: Not a Combination Product	12/01/2018
2	NDC: 0316-0226-08	226.8 g in 1 JAR; Type 0: Not a Combination Product	12/01/2018
3	NDC: 0316-0226-16	453.6 g in 1 JAR; Type 0: Not a Combination Product	12/01/2018

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

Labeler - Crown Laboratories (079035945)