FDA.reportPublic FDA data

ASTONEA Cold Ice Analgesic Gel

Manufacturer
ASTONEA LABS PRIVATE LIMITED
Effective date
2024-06-25
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:14:17

Label at a glance#

ProductASTONEA Cold Ice Analgesic Gel
Active ingredientMENTHOL
Label structure11 sections

Indications and uses

for temporary relief of minor aches and pains in muscles and joints associated with: simple backaches, strains sprains sports injuries arthritis bruises

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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 2.0%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses:

INDICATIONS & USAGE SECTION

  • for temporary relief of minor aches and pains in muscles and joints associated with:
  • simple backaches,
  • strains
  • sprains
  • sports injuries
  • arthritis
  • bruises

Warnings

WARNINGS SECTION

FOR EXTERNAL USE ONLY

Do not use:

  • with other topical pain relievers
  • with heating pads or heating devices

When using this product

OTC - WHEN USING SECTION

  • do not use in or near eyes
  • do not apply to wounds or damaged skin
  • do not bandage tightly

Stop use and ask a doctor if

OTC - ASK DOCTOR SECTION

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days
  • redness or irritation develops

If pregnant or breastfeeding

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 swallowed get Medical Help or contact a Poison Control Center 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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

ammonium hydroxide, carbomer, cupric sulfate, FD&C Blue No. 1, isopropyl alcohol, magnesium sulfate, sodium hydroxide, thymol, water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display and Drug Fact PanelPrincipal Display and Drug Fact Panel

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
77338-402-122024-06-25C16284748780-11030e365-2c98-111a-e063-dadaa90a10e2Astonea Cold Ice Gel
77338-402-122024-01-30C16284748780-11030e365-2c98-111a-e063-dadaa90a10e2Astonea Cold Ice Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77338-402-12ASTONEA Cold Ice Analgesic Gel227 g in 1 JARGEL2273

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77338-402ASTONEA COLD ICE ANALGESIC GEL (MENTHOL) GEL [ASTONEA LABS PRIVATE LIMITED]3Legacy NDC, 1 package rows20240627_e5c0c190-042d-616f-e053-2995a90a25d2.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77338-40277338-402-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
AMMONIA5138Q19F1XIACT
ISOPROPYL ALCOHOLND2M416302IACT
CUPRIC SULFATELRX7AJ16DTIACT
THYMOL3J50XA376EIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
WATER059QF0KO0RIACT
SODIUM HYDROXIDE55X04QC32IIACT
MENTHOLL7T10EIP3AACTIB
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
MAGNESIUM SULFATE, UNSPECIFIEDDE08037SABIACT

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
1bbb498e-e6cb-fa2d-e063-6394a90a271be5c0c190-042d-616f-e053-2995a90a25d22024-06-25WarningsExact identifier
spl id: 1bbb498e-e6cb-fa2d-e063-6394a90a271b
spl set id: e5c0c190-042d-616f-e053-2995a90a25d2

Reported adverse events (FAERS/openFDA)#

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