FDA.reportPublic FDA data

HealthWise Pain Relieving Menthol Gel

Manufacturer
Veridian Healthcare | Jell Pharmaceuticals Pvt Ltd.
Effective date
2025-12-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:27:44

Label at a glance#

ProductHealthWise Pain Relieving Menthol Gel
Active ingredientMENTHOL
Label structure9 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 clean affected area before applying product Adults and children 2 years of age and older apply to the affected area not more than 3 to 4 times daily Children under 2 years of age, ask a doctor before using this product

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 2%

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

When using this product, do not

OTC - WHEN USING SECTION

When using this product:

■ do not use with other topical pain relievers

■do not use with a heating pads or other heating devices

■ avoid contact with eyes 

■do not bandage tightly

■ do not apply to wounds or damaged skin

Stop use and ask a doctor if

OTC - STOP USE SECTION

Stop use and ask a doctor if: the condition worsens, or if symptoms persist for more than 7 days or clear up and occur again withing a few days.

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 orcontact a Poison Control Center (800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions

  • clean affected area before applying product
  • Adults and children 2 years of age and older apply to the affected area not more than 3 to 4 times daily
  • Children under 2 years of age, ask a doctor before using this product

Other information

OTHER SAFETY INFORMATION

  • do not freeze
  • store at room temperature
  • keep container tightly closed when  not in use
  • do not use, pour, spill or store near heat or open flame

Inactive ingredients

INACTIVE INGREDIENT SECTION

ammonium hydroxide, carbopol 940, cupric sulfate, FD&C blue No. 1, Isopropyl alcohol, magnesium sulphate, PEG-40 hydrogenated castor oil sodium hydroxide, thymol, water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71101-091-01HealthWise Pain Relieving Menthol Gel1 in 1 BOXGEL11
71101-091-01HealthWise Pain Relieving Menthol Gel226.8 mL in 1 BOTTLEGEL226.81

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71101-09171101-091-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
AMMONIA5138Q19F1XIACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EIACT
CUPRIC SULFATELRX7AJ16DTIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
ISOPROPYL ALCOHOLND2M416302IACT
MAGNESIUM SULFATE ANHYDROUSML30MJ2U7IIACT
THYMOL3J50XA376EIACT
WATER059QF0KO0RIACT
SODIUM HYDROXIDE55X04QC32IIACT
PEG-40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
MENTHOLL7T10EIP3AACTIB

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 Pain Relieving Menthol GelMENTHOL 2%Veridian Healthcare396d0fd4-67be-4de1-8f0c-42c83dfe91202025-12-22WarningsExact identifier
ndc (package): 71101-091-01
ndc (product): 71101-091
ndc11 (package): 71101009101
spl id: 468dec7c-4f08-b711-e063-6294a90a6f74
spl set id: 396d0fd4-67be-4de1-8f0c-42c83dfe9120

Reported adverse events (FAERS/openFDA)#

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