Cold Zone Pain Relieving Gel- DG Health

Manufacturer
SOTAC PHARMACEUTICALS PRIVATE LIMITED
Effective date
2018-07-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:56:19

Label at a glance#

ProductCold Zone Pain Relieving Gel- DG Health
Active ingredientMENTHOL
Label structure14 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

Storage and handling

Keep away from excessive heat or open flame.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION


Menthol USP 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:

STORAGE AND HANDLING 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 irritated 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 - STOP USE 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 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:

SPL UNCLASSIFIED SECTION

Store in a cool dry place with lid closed tightly

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Purified water, Glycerin, Isopropyl alcohol, Iso propyl myristate, Carbopol usp, Aloevera gel, Arnica montana flower extract, Articum lappa root (burdock) extract, Boswellia carterii resin extract, Calendula officinalis extract, Camellia sinensis leaf extract, Iiex paraguariensis leaf extract, Melissa officinalis (lemon balm) leaf extract, Tocopheryl acetate, Triethanolamine, Colloidal silicon dioxide, Sorbic acid, Camphor, Brillient blue, Tartrazin supra

Cold Zone Pain Relieving Gel- DG Health

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Lable- Bulk

DG_Cold Zone Pain Relief Gel_2 fl oz_shipper LabelDG_Cold Zone Pain Relief Gel_2 fl oz_shipper Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
415974menthol 4 % Topical GelPSN2
415974menthol 0.04 MG/MG Topical GelSCD2
415974menthol 4 % Topical GelSY2

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130376168401417GTIN-13: 0376168401417
EAN-13: 0376168401417
GTIN-12: 376168401417
UPC-A: 376168401417
GTIN storage (14 digits): 00376168401417
DG_Cold Zone Pain Relief Gel_2 fl oz_shipper Label.jpg

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
72351-001-002021-01-29C16284748780-1ba0f9c33-54bf-a910-e053-dadaa90a0b85Cold Zone Pain Relieving Gel- DG Health

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72351-001-00Cold Zone Pain Relieving Gel- DG Health59.14 mL in 1 TUBEGEL59.142
72351-001-00Cold Zone Pain Relieving Gel- DG Health96 in 1 PACKAGEGEL962

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72351-001COLD ZONE PAIN RELIEVING GEL- DG HEALTH (MENTHOL) GEL [SOTAC PHARMACEUTICALS PRIVATE LIMITED]2Legacy NDC, 2 package rows20180718_8f3c4fe8-aa9e-4e27-8d02-cab5b7a904f7.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72351-00172351-001-00

Ingredients#

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

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

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
714b1a50-3e8b-6162-e053-2995a90a7f188f3c4fe8-aa9e-4e27-8d02-cab5b7a904f72018-07-18WarningsExact identifier
spl id: 714b1a50-3e8b-6162-e053-2995a90a7f18
spl set id: 8f3c4fe8-aa9e-4e27-8d02-cab5b7a904f7

Reported adverse events (FAERS/openFDA)#

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