43473-098 4% MENTHOL COLD THERAPY GEL

Manufacturer
Nantong Health & Beyond Hygienic Products Inc.
Effective date
2026-02-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:37:17

Label at a glance#

Product4% MENTHOL COLD THERAPY
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure9 sections

Indications and uses

• for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains • provides cooling pain relief

Dosage and administration

• 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: do not use, consult a doctor • wash hands after use with cool water

Storage and handling

• store in a cool dry place away from direct sunlight • store with cap closed tightly

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 4%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

• for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains • provides cooling pain relief

Warnings

WARNINGS SECTION

For external use only

When using this product
•
avoid contact with eyes • do not apply to wounds or damaged skin 
• do not bandage tightly • do not use with heating pads or heating devices

Stop use and consult a doctor ifcondition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

Flammable: Keep away from excessive heat or open flame

If pregnant or breastfeeding,ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

• 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: do not use, consult a doctor
• wash hands after use with cool water

Other information

STORAGE AND HANDLING SECTION

• store in a cool dry place away from direct sunlight • store with cap closed tightly

Inactive ingredients

INACTIVE INGREDIENT SECTION

Arnica Montana Flower Extract, Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, Arctium Lappa Extract, Butylene Glycol, Boswellia Serrata Resin Extract, Camphor, Carbomer, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, FD&C Blue No.1, Glycerin, Isopropyl Alcohol, Isopropyl Myristate, Ilex Paraguariensis Leaf Extract, Melissa Officinalis Leaf Extract, Methyl Methacrylate Crosspolymer, Tocopheryl Acetate, Water, Yellow No.5

SPL UNCLASSIFIED SECTION

Compare to Biofreeze® Menthol Pain Relieving Gel active ingredient

Cooling Pain Relief | Menthol Topical Analgesic

For Minor Aches & Muscle Pain

COOLING MENTHOL FORMULA

• For Arthritis Backache
• Joint & Muscle Pain
• Fast-Acting and Long-Lasting

Mfd for and Distributed by:
Universal Distribution Center LLC
330 Applegarth Road,
Monroe Township, NJ 08831

www.universaldc.com

MADE IN CHINA

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4% MENTHOL COLD THERAPY GEL4% MENTHOL COLD THERAPY GEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
415974menthol 4 % Topical GelPSN1
415974menthol 0.04 MG/MG Topical GelSCD1
415974menthol 4 % Topical GelSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130676979560939GTIN-13: 0676979560939
EAN-13: 0676979560939
GTIN-12: 676979560939
UPC-A: 676979560939
GTIN storage (14 digits): 00676979560939
52000442-2.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43473-098-154% MENTHOL COLD THERAPY42.5 g in 1 TUBEGEL42.51
43473-098-154% MENTHOL COLD THERAPY1 in 1 BOXGEL11

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
43473-09843473-098-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 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
4% MENTHOL COLD THERAPYMENTHOLNantong Health & Beyond Hygienic Products Inc.7acc7282-ef4f-41ec-b51d-a88dfed79bd72026-02-05WarningsExact identifier
ndc (package): 43473-098-15
ndc (product): 43473-098
ndc11 (package): 43473009815
spl id: 4a2141c8-1409-3c77-e063-6294a90a5427
spl set id: 7acc7282-ef4f-41ec-b51d-a88dfed79bd7

Reported adverse events (FAERS/openFDA)#

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