FDA.reportPublic FDA data

Pain Relief Cold Therapy Gel 3 FL OZ

Manufacturer
SOTAC PHARMACEUTICAL PRIVATE LIMITED
Effective date
2022-12-31
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:52:49

Label at a glance#

ProductPain Relief Cold Therapy Gel 3 FL OZ
Active ingredientMENTHOL
Label structure9 sections

Indications and uses

Temporary relief from minor aches and pains of sore muscles and joints associated with •arthritis •backache •strains •sprains

Dosage and administration

• Adults and children 2 years of age and older: rub a thin film over affected areas not more than 4 times daily, massage not necessary • Children under 2 years of age: consult physician

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 4%

Purpose

OTC - PURPOSE SECTION

Cooling Pain Relief

Uses

INDICATIONS & USAGE SECTION

Temporary relief from minor aches and pains of sore muscles and
joints associated with •arthritis •backache •strains •sprains

Warnings

WARNINGS SECTION

For external use only

Flammable

WARNINGS SECTION

Keep away from excessive heat or open flame

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

sensitive skin

When using this product

OTC - WHEN USING SECTION

• avoid contact with the eyes or mucous membranes

• do not apply to wounds or damaged skin

• do not use with other ointments, creams, sprays or liniments

• do not apply to irritated skin or if excessive irritation develops

• do not bandage

• wash hands after use with cool water

• do not use with heating pad or device

Stop use and ask a doctor if

OTC - ASK DOCTOR/PHARMACIST SECTION

condition worsens, or if symptoms persist for more than 7 days, or clear up and recur

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 accidentally ingested, get medical help or contact a Poison Control Center (1-800-222-1222) immediately

Directions

DOSAGE & ADMINISTRATION SECTION

• Adults and children 2 years of age and older: rub a thin film over affected areas not more than 4 times daily, massage not necessary

• Children under 2 years of age: consult physician

Other Information

OTHER SAFETY INFORMATION

• store in a cool dry place

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe vera gel, arnica montana flower extract, articum lappa root (burdock) extract, boswellia carterii resin extract, calendula officinalis extract, camellia sinensis (green tea) leaf extract, camphor, carbomer 934, colloidal silicon dioxide, FD&C blue no.1, FD&C yellow no.5, glycerin, ilex paraguariensis leaf extract, isopropyl alcohol, isopropyl myristate, melissa officinalis (lemon balm) leaf extract, purified water, sorbic acid, tocopheryl acetate, triethanolamine

Questions or comments

OTC - QUESTIONS SECTION

1-856-357-7321

Pain Relief Cold Therapy Gel 3 FL OZ

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cold Therapy Gel 3 FL OZCold Therapy Gel 3 FL OZ

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
415974menthol 4 % Topical GelPSN4
415974menthol 0.04 MG/MG Topical GelSCD4
415974menthol 4 % Topical GelSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a7d4b4db-013e-463b-a016-c04dc0b3d6a2Product name120200604

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72351-641-032024-01-30C16284748780-11030e365-5b36-111a-e063-dadaa90a10e2bbbe4a23-17ba-64d6-e053-2a95a90ac801

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72351-641-03Pain Relief Cold Therapy Gel 3 FL OZ88.72 mL in 1 TUBEGEL88.724

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72351-641PAIN RELIEF COLD THERAPY GEL 3 FL OZ (MENTHOL 4% GEL) GEL [SOTAC PHARMACEUTICAL PRIVATE LIMITED]4Legacy NDC, 1 package rows20230101_bbbe4a23-17ba-64d6-e053-2a95a90ac801.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72351-64172351-641-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
SILICON DIOXIDEETJ7Z6XBU4IACT
MENTHOLL7T10EIP3AACTIB
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
WATER059QF0KO0RIACT
ARCTIUM LAPPA ROOT597E9BI3Z3IACT
ISOPROPYL ALCOHOLND2M416302IACT
FD&C YELLOW NO. 5I753WB2F1MIACT
CAMPHOR (NATURAL)N20HL7Q941IACT
CARBOMER 934Z135WT9208IACT
GLYCERINPDC6A3C0OXIACT
FRANKINCENSER9XLF1R1WMIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
ILEX PARAGUARIENSIS LEAF1Q953B4O4FIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
TROLAMINE9O3K93S3TKIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
BRILLIANT BLUE GM1ZRX790SIIACT
MELISSA OFFICINALIS LEAF50D2ZE9219IACT
ALOE VERA LEAFZY81Z83H0XIACT
SORBIC ACIDX045WJ989BIACT

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
f11f3ff1-c677-7b9c-e053-2a95a90aea33bbbe4a23-17ba-64d6-e053-2a95a90ac8012022-12-31WarningsExact identifier
spl id: f11f3ff1-c677-7b9c-e053-2a95a90aea33
spl set id: bbbe4a23-17ba-64d6-e053-2a95a90ac801

Reported adverse events (FAERS/openFDA)#

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