FDA.reportPublic FDA data

Theracare Ice Blue Gel

Manufacturer
Veridian Healthcare | ANICARE PHARMACEUTICALS PRIVATE LIMITED
Effective date
2024-12-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:45:01

Label at a glance#

ProductTheracare Ice Blue Gel Pain Relieving
Active ingredientMENTHOL
Label structure13 sections

Indications and uses

● temporarily relieves minor aches and pains of muscles and joints associated with: ● simple backache ● arthritis ● strains ● bruises ● sprains

Dosage and administration

clean affected area before applying product 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: ask a doctor before using this product

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 2%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

● temporarily relieves minor aches and pains of muscles and joints associated with:

● simple backache

● arthritis

● strains

● bruises

● sprains

Warnings

WARNINGS SECTION

For external use only

When Using this product

OTC - DO NOT USE SECTION

  • with other topical pain relievers
  • with heating pads or heating devices
  • avoid contact with eyes
  • do not bandage tightly
  • do not apply to wounds or damage skin

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days

If pregnant or breast-feeding

OTC - ASK DOCTOR/PHARMACIST SECTION

ask a health professional before use

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center (800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • clean affected area before applying product
  • 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: ask a doctor before using this product

Other information

STORAGE AND HANDLING SECTION

  • 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, benzyl alcohol, carbopor 940, cupric sulfate, FD&C blue no. 1, isopropyl alcohol, magnesium sulfate, PEG-40 hydrogenated castor oil, sodium hydroxide, thymol, water

Questions or comments?

OTC - QUESTIONS SECTION

Customer care 866-326-1313

Principal Display

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311502menthol 2 % Topical GelPSN3
311502menthol 0.02 MG/MG Topical GelSCD3
311502menthol 2 % Topical GelSY3
311502menthol 2 % topical stickSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71101-217-012025-07-29C16284748780-13b156c62-2cc1-fb37-e063-e6dba90a4e07Theracare Ice Blue Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71101-217-01Theracare Ice Blue GelPain Relieving226.8 g in 1 JARGEL226.83

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71101-217THERACARE ICE BLUE GEL PAIN RELIEVING (MENTHOL) GEL [VERIDIAN HEALTHCARE]3Legacy NDC, 1 package rows20241220_d61eb82f-782b-e08b-e053-2a95a90a10ff.zip

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
71101-21771101-217-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
BENZYL ALCOHOLLKG8494WBHIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
AMMONIA5138Q19F1XIACT
CARBOMER 9404Q93RCW27EIACT
CUPRIC SULFATELRX7AJ16DTIACT
ISOPROPYL ALCOHOLND2M416302IACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT
SODIUM HYDROXIDE55X04QC32IIACT
THYMOL3J50XA376EIACT
WATER059QF0KO0RIACT
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
299510e6-81c4-220e-e063-6394a90a10a2d61eb82f-782b-e08b-e053-2a95a90a10ff2024-12-18WarningsExact identifier
spl id: 299510e6-81c4-220e-e063-6394a90a10a2
spl set id: d61eb82f-782b-e08b-e053-2a95a90a10ff

Reported adverse events (FAERS/openFDA)#

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