HealthWise Soothing Cold Therapy Gel

Manufacturer
Veridian Healthcare | Nantong Health & Beyond Hygienic Products Inc.
Effective date
2024-08-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:16:53

Label at a glance#

ProductHealthWise Soothing Cold Therapy Gel
Active ingredientMENTHOL
Label structure8 sections

Indications and uses

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

Dosage and administration

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION


Menthol 4%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

Uses 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: 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, do not

OTC - WHEN USING SECTION

When using this product:

■ avoid contact with 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 a heating pad or device

Stop use and ask a doctor if

OTC - STOP USE SECTION

Stop use and ask a doctor if: the condition worsens, if the symptoms last more than 7 days or clear up and reoccur

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center (800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions

Adults and children 2 years of age and older:■rub a thin film over affected area 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
  • do not use if tube seal under cap is broken

Inactive ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients aloe barbadensis leaf juice, aminomethyl propanol,arctium lappa extract, arnica montana flower extract, Boswellia serrata extract, calendula officinalis flower extract, camellia sinensis leaf extract, camphor, carbomer, FD&Cyellow
no.5, FD&C blue no.1, glycerin, ilex paraguariensis leaf extract, isopropyl alcohol,isopropyl myristate, melissa officinalis leaf extract, methyl methacrylate crosspolymer, tocopheryl acetate, water

HealthWise Soothing Cold Therapy Gel 4% Menthol

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71101-050-01HealthWise Soothing Cold Therapy Gel88.7 mL in 1 BOTTLEGEL88.72
71101-050-01HealthWise Soothing Cold Therapy Gel1 in 1 BOXGEL12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71101-050HEALTHWISE SOOTHING COLD THERAPY GEL (MENTHOL 4%) GEL [VERIDIAN HEALTHCARE]2Current NDC, 2 package rows20240809_1f09ccdd-09d8-6a8d-e063-6394a90a184f.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71101-05071101-050-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 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
HealthWise Soothing Cold Therapy GelMENTHOL 4%Veridian Healthcare1f09ccdd-09d8-6a8d-e063-6394a90a184f2024-08-08WarningsExact identifier
ndc (package): 71101-050-01
ndc (product): 71101-050
ndc11 (package): 71101005001
spl id: 1f2ef992-1262-4b39-e063-6394a90a6dd9
spl set id: 1f09ccdd-09d8-6a8d-e063-6394a90a184f

Reported adverse events (FAERS/openFDA)#

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