ASTONEA COLD THERAPY

Manufacturer: ASTONEA LABS PRIVATE LIMITED
Effective date: 2024-03-12
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 00:09:41

Label at a glance#

ProductASTONEA COLD THERAPY

Active ingredientMENTHOL

Label structure7 sections

Contacts and useful links#

PhonePoison Help1800-222-1222

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Menthol 4%

OTC - PURPOSE SECTION

Topical Analgesic

INDICATIONS & USAGE SECTION

Temporary relief from minor aches and pains of sore muscles and joints associated with:

arthritis

backache

strains

sprains

WARNINGS SECTION

For external use only

Flammable:Keep away from excessive heat or open flame

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have: sensitive skin

Stop use and ask a doctor if

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

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 alter use with cool water ■do not use with heating pad or device

OTC - PREGNANCY OR BREAST FEEDING SECTION

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 accidentally ingested, get medical help or contact a poison Control immediately (1800-222-1222)

DOSAGE & ADMINISTRATION SECTION

Directions

Adults and children 2 years of age and older:Rub a thin film over affected areas not more than daily: massage not necessary

Children under 2 years of age :Consult physician

INACTIVE INGREDIENT SECTION

camphor, carbopol 940, DMDM hydantoin, edetate disodium, FD&C yellow no. 5, FD&C blue no. 1, isopropyl alcohol, PEG 40

hydrogenated castor oil, propylene glycol, sodium hydroxide, water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display and Drug Fact Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
415974	menthol 4 % Topical Gel	PSN	1
415974	menthol 0.04 MG/MG Topical Gel	SCD	1
415974	menthol 4 % Topical Gel	SY	1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
77338-007-04	ASTONEA COLD THERAPY	118.2 g in 1 TUBE	GEL	118.2		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
77338-007	ASTONEA COLD THERAPY (MENTHOL 4%) GEL [ASTONEA LABS PRIVATE LIMITED]	1	1 package rows	20240314_137cec16-20e9-ab5c-e063-6294a90a11db.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

ASTONEA COLD THERAPY
Menthol 4%
POLYETHYLENE GLYCOL 2000
GLYCERIN
DMDM HYDANTOIN
EDETATE SODIUM
CARBOMER 940
ISOPROPYL ALCOHOL
FD&C YELLOW NO. 5
FD&C BLUE NO. 1
HYDROGENATED CASTOR OIL
SODIUM HYDROXIDE
WATER
CAMPHOR (SYNTHETIC)
MENTHOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
77338-007	77338-007-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
POLYETHYLENE GLYCOL 2000	HAF0412YIT	IACT
GLYCERIN	PDC6A3C0OX	IACT
DMDM HYDANTOIN	BYR0546TOW	IACT
EDETATE SODIUM	MP1J8420LU	IACT
CARBOMER 940	4Q93RCW27E	IACT
ISOPROPYL ALCOHOL	ND2M416302	IACT
FD&C YELLOW NO. 5	I753WB2F1M	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
HYDROGENATED CASTOR OIL	ZF94AP8MEY	IACT
SODIUM HYDROXIDE	55X04QC32I	IACT
WATER	059QF0KO0R	IACT
CAMPHOR (SYNTHETIC)	5TJD82A1ET	IACT
MENTHOL	L7T10EIP3A	ACTIB

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
137cfc8f-c027-022a-e063-6394a90ac727			137cec16-20e9-ab5c-e063-6294a90a11db	2024-03-12	Warnings	Exact identifier spl id: 137cfc8f-c027-022a-e063-6394a90ac727 spl set id: 137cec16-20e9-ab5c-e063-6294a90a11db

Reported adverse events (FAERS/openFDA)#

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