FDA.reportPublic FDA data

MINERAL ICE

Manufacturer
Voyant Beauty, Inc.
Effective date
2023-04-28
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 21:32:27

Label at a glance#

ProductMINERAL ICE
Active ingredientMENTHOL
Label structure11 sections

Indications and uses

Temporarily relieves minor aches and pains of muscles and joints associated with: Arthritis simple backache strains Bruises sport injuries sprains Provides cooling penetrating relief

Dosage and administration

Clean affected area before applying Adults and children 2 years of age and older: apply in affected area not more than 3 to 4 times daily Children under 2 years of age, ask a doctor

Storage and handling

Store at controlled temperature 20 to 25C (68-77F) in a tightly cleaned container Do not use, pour, spill or store near heat or open flame

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

MINERAL ICE

DRUG FACTS

Active Ingredients

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
  • sport injuries
  • 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 yes
  • Do not apply to wounds or damaged skin
  • Do not bandage tightly

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • Conditions worsens
  • Symptoms last more than 7 days or clear up and occur again within a few days
  • Redness or irritation develops

If pregnant or breast-feeding:

OTC - PREGNANCY OR BREAST FEEDING 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
  • Adults and children 2 years of age and older: apply in 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 controlled temperature 20 to 25C (68-77F) in a tightly cleaned container
  • 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/comments?

SPL UNCLASSIFIED SECTION

1-855-328-5258

PRINCIPAL DISPLAY PANEL 8 oz (226.8g)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0316-0226-08

Original Theraputic

MINERAL
ICE

MENTHOL PAIN

RELIEVING GEL


Greaseless
With DEEPCOLD PAIN RELIEVER


Net Wt 8 oz (226.8 g)

8oz wrap label8oz wrap label

PRINCIPAL DISPLAY PANEL 16oz (453.6g)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0316-0226-16

Original Theraputic

MINERAL
ICE

MENTOL PAIN

RELIEVING GEL

Greaseless

With DEEPCOLD Pain Reliever

Net Wt 16 oz (453.6 g)

16oz wrap label16oz wrap label

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
61047-20261047-202-01, 61047-202-02, 61047-202-03, 61047-202-05, 61047-202-06

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 B (ALLYL PENTAERYTHRITOL CROSSLINKED)HHT01ZNK31IACT
CUPRIC SULFATELRX7AJ16DTIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
ISOPROPYL ALCOHOLND2M416302IACT
MAGNESIUM SULFATE, UNSPECIFIEDDE08037SABIACT
WATER059QF0KO0RIACT
SODIUM HYDROXIDE55X04QC32IIACT
THYMOL3J50XA376EIACT
MENTHOLL7T10EIP3AACTIB

Source Document#

Source XML

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
fa66f019-6d16-903d-e053-6394a90a1188fcc6a38a-0280-4766-b035-e2f0601657d82023-04-28WarningsExact identifier
spl id: fa66f019-6d16-903d-e053-6394a90a1188
spl set id: fcc6a38a-0280-4766-b035-e2f0601657d8

Reported adverse events (FAERS/openFDA)#

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