FDA Label for Mineral Ice Pain Relieving

View Indications, Usage & Precautions

Mineral Ice Pain Relieving Product Label

The following document was submitted to the FDA by the labeler of this product Crown Laboratories. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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


* Please review the disclaimer below.