FDA.reportPublic FDA data

NATURES REALM COOL HOT ICE ANALGESIC

Manufacturer
Viny Health and Beauty Inc
Effective date
2018-01-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:03:56

Label at a glance#

ProductNATURES REALM COOL HOT ICE ANALGESIC
Active ingredientMenthol
Label structure8 sections

Indications and uses

temporary relief of minor aches and pains in muscles and joints associated with simple backache strains, sprains, arthritis and sports injuries.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 1.0%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

  • temporary relief of minor aches and pains in muscles and joints associated with simple backache strains, sprains, arthritis and sports injuries.

Warning

WARNINGS SECTION

For external use only.

Use only as directed. Avoid contact with eyes or mucous membranes. Do not apply to open wounds or damaged skin. Make sure skin is clean and free from any creams, ointments, sprays or liniment. Do not bandage.


Do not use with heating pads or heating devices.
If condition worsens or symptoms persist for more than 7 days or if symptoms disappear and occur again within a few days, discontinue use and consult a physician. If you have sensitive skin, consult a physician before use. If skin irritation develops, discontinue use and consult a physician. If you are pregnant or nursing a baby, consult your doctor before use. Do not use, store, pour or spill near heat or open flame. Store in a cool, dry place and keep lid tightly closed.



Direction

DOSAGE & ADMINISTRATION SECTION

Clean skin of all other lotions, creams, ointments, liniment or sprays. Apply liberally to affected area and massage until gel is absorbed into skin. Do not apply more than 3 or 4 times daily. No protective cover needed. Do not apply to children under 2 years of age.

Other Ingredients

INACTIVE INGREDIENT SECTION

Water, Isopropyl Alcohol, Nonoxynol-10, Camphor, Carbomer, Sodium Hydroxide, Methylchloroisothiazolinone, Methylisothiazolinone,

Blue 1 (CI 42090).

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION


Keep out of reach of children. If swallowed, get medical help or contact Poison Control  Center  right away.


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LBL_Natures Realm_Cool-Hot IceLBL_Natures Realm_Cool-Hot Ice

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
76436-23376436-233-08

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
MentholL7T10EIP3AACTIB
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302IACT
CAMPHOR (SYNTHETIC)5TJD82A1ETIACT
CARBOMER 934Z135WT9208IACT
SODIUM HYDROXIDE55X04QC32IIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
NONOXYNOL-10K7O76887APIACT
FD&C BLUE NO. 1H3R47K3TBDIACT

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
39c2fd8e-b651-4df1-a420-24101c00ae7fbea5c047-3311-4881-8cc7-d68dff8499342018-01-30WarningsExact identifier
spl id: 39c2fd8e-b651-4df1-a420-24101c00ae7f
spl set id: bea5c047-3311-4881-8cc7-d68dff849934

Reported adverse events (FAERS/openFDA)#

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