Mineral Ice

Mineral Ice
SPL v10
SPL
SPL Set ID 7b30076a-0af6-2f74-e053-2a91aa0ae08d
Route
TOPICAL
Published
Effective Date 2023-11-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (20 mg)
Inactive Ingredients
Ammonia Carbomer Homopolymer Type B Cupric Sulfate Fd&c Blue No. 1 Isopropyl Alcohol Magnesium Sulfate Heptahydrate Sodium Hydroxide Thymol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2011-11-01 Until 2025-01-31

Description

Menthol 2%

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Menthol 2%

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

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
Do Not Use
  • with other topical pain relievers
  • with heating pads or heating devices
Active Ingredient

Menthol 2%

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
Principal Display

NDC 0316-0226-08

ORIGINAL THERAPEUTIC

Mineral Ice®

Menthol Pain Relieving Gel

Greaseless with DEEPCOLD® Pain Reliever

Net wt. 8 oz (226.8 g)

P11529.00

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

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.

Additional Information Listed On Other Panels

1-833-279-6522 ©Crown Laboratories, Inc.

Distributed by: Crown Laboratories, Inc.

Johnson City, TN 37604 ©2018 Made in Canada.

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


Structured Label Content

Uses

● temporarily relieves minor aches and pains of muscles and joints associated with:

● arthritis ● simple backache ● strains

  • ● bruises ● sprains

● provides cooling penetrating relief

Purpose

Topical analgesic

Warnings

For external use only

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
Do Not Use (Do not use)
  • with other topical pain relievers
  • with heating pads or heating devices
Active Ingredient (Active ingredient)

Menthol 2%

Other Information (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
Principal Display

NDC 0316-0226-08

ORIGINAL THERAPEUTIC

Mineral Ice®

Menthol Pain Relieving Gel

Greaseless with DEEPCOLD® Pain Reliever

Net wt. 8 oz (226.8 g)

P11529.00

Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

call 1-833-279-6522

When Using This Product (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 (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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.

Additional Information Listed On Other Panels (Additional Information Listed on Other Panels)

1-833-279-6522 ©Crown Laboratories, Inc.

Distributed by: Crown Laboratories, Inc.

Johnson City, TN 37604 ©2018 Made in Canada.

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


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Raw Label Data

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