Mineral Ice Gel
FDA Label NDC 0316-0226

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Crown Laboratories for the product Mineral Ice (NDC 0316-0226). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

P1152900 (P1152900 Minice 8oz Label)

P1152900 (P1152900 Minice 8oz Label)

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