FDA.reportPublic FDA data

Mineral Ice

Manufacturer
Crown Laboratories
Effective date
2026-01-12
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 01:32:38

Label at a glance#

ProductMineral Ice Pain Relieving
Active ingredientMENTHOL
Label structure10 sections

Indications and uses

● temporarily relieves minor aches and pains of muscles and joints associated with: ● arthritis ● simple backache ● strains ● bruises ● sprains ● provides cooling penetrating relief

Dosage and administration

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

Storage and handling

store at 20 o - 25 o C (68 o - 77 o F) [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

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 2%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

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

● arthritis ● simple backache ● strains

  • ● bruises ● sprains

● provides cooling penetrating relief

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • with other topical pain relievers
  • with heating pads or heating devices

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

If pregnant or breast-feeding,

OTC - ASK DOCTOR/PHARMACIST SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

call 1-833-279-6522

Additional Information Listed on Other Panels

SPL UNCLASSIFIED SECTION

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.

Principal Display

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

p1152900p1152900

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311502menthol 2 % Topical GelPSN10
692869Mineral Ice 2 % Topical GelPSN10
692869menthol 0.02 MG/MG Topical Gel [Mineral ice]SBD10
311502menthol 0.02 MG/MG Topical GelSCD10
311502menthol 2 % Topical GelSY10
311502menthol 2 % topical stickSY10
692869Mineral ice 0.02 MG/MG Topical GelSY10
692869Mineral Ice 2 % Topical GelSY10

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0316-0226-082023-02-13C16284748780-1f386c64a-1fba-0266-e053-dadaa90a7c1aMineral Ice
0316-0226-082023-02-13C16284748780-1f386c64a-1fba-0266-e053-dadaa90a7c1aMineral Ice
0316-0226-162023-02-13C16284748780-1f386c64a-1fba-0266-e053-dadaa90a7c1aMineral Ice
0316-0226-162023-02-13C16284748780-1f386c64a-1fba-0266-e053-dadaa90a7c1aMineral Ice
0316-0226-352023-02-13C16284748780-1f386c64a-1fba-0266-e053-dadaa90a7c1aMineral Ice
0316-0226-352023-02-13C16284748780-1f386c64a-1fba-0266-e053-dadaa90a7c1aMineral Ice
0316-0226-082023-01-30C16284748780-1f386c64a-1fba-0266-e053-dadaa90a7c1aMineral Ice
0316-0226-082023-01-30C16284748780-1f386c64a-1fba-0266-e053-dadaa90a7c1aMineral Ice
0316-0226-162023-01-30C16284748780-1f386c64a-1fba-0266-e053-dadaa90a7c1aMineral Ice
0316-0226-162023-01-30C16284748780-1f386c64a-1fba-0266-e053-dadaa90a7c1aMineral Ice
0316-0226-352023-01-30C16284748780-1f386c64a-1fba-0266-e053-dadaa90a7c1aMineral Ice
0316-0226-352023-01-30C16284748780-1f386c64a-1fba-0266-e053-dadaa90a7c1aMineral Ice

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0316-0226-08Mineral IcePain Relieving226.8 g in 1 JARGEL226.810
0316-0226-16Mineral IcePain Relieving453.6 g in 1 JARGEL453.610
0316-0226-35Mineral IcePain Relieving99.2 g in 1 JARGEL99.210

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0316-0226-08GM - Gram0316-02263255328b-3c3f-4a59-b8cf-0a6260a04ff312019-01-24
0316-0226-16GM - Gram0316-0226a83889a9-604a-4ed1-9019-79339c76204712019-01-24
0316-0226-35GM - Gram0316-02265f2ef2a1-c39d-4b1d-af51-30d33c3f9ebc12019-01-24

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0316-02260316-0226-35, 0316-0226-08, 0316-0226-16

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
AMMONIA5138Q19F1XIACT
CARBOMER HOMOPOLYMER TYPE BHHT01ZNK31IACT
CUPRIC SULFATELRX7AJ16DTIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
ISOPROPYL ALCOHOLND2M416302IACT
MAGNESIUM SULFATE HEPTAHYDRATESK47B8698TIACT
SODIUM HYDROXIDE55X04QC32IIACT
THYMOL3J50XA376EIACT
WATER059QF0KO0RIACT
MENTHOLL7T10EIP3AACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
92025-11-12monthly-update2026-06-03 17:40:06

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mineral Ice Pain RelievingMENTHOLCrown Laboratories7b30076a-0af6-2f74-e053-2a91aa0ae08d2026-01-12WarningsExact identifier
ndc (package): 0316-0226-08
ndc (package): 0316-0226-16
ndc (package): 0316-0226-35
ndc (product): 0316-0226
ndc11 (package): 00316022608
ndc11 (package): 00316022635
ndc11 (package): 00316022616
spl id: 4833e9dd-2f42-f6d5-e063-6394a90a1b0a
spl set id: 7b30076a-0af6-2f74-e053-2a91aa0ae08d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.