ASTONEA COLD THERAPY- menthol 4% gel

ASTONEA COLD THERAPY by

Drug Labeling and Warnings

ASTONEA COLD THERAPY by is a Otc medication manufactured, distributed, or labeled by ASTONEA LABS PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Menthol 4%

PURPOSE

Topical Analgesic

INDICATIONS & USAGE

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

arthritis

backache

strains

sprains

WARNINGS

For external use only

Flammable:Keep away from excessive heat or open flame

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.

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

If pregnant or breastfeeding, ask a health professional before use

Keep out of reach of children: If accidentally ingested, get medical help or contact a poison Control immediately (1800-222-1222)

DOSAGE & ADMINISTRATION

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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ASTONEA COLD THERAPY 
menthol 4% gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77338-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL 2000 (UNII: HAF0412YIT)
GLYCERIN (UNII: PDC6A3C0OX)
DMDM HYDANTOIN (UNII: BYR0546TOW)
EDETATE SODIUM (UNII: MP1J8420LU)
CARBOMER 940 (UNII: 4Q93RCW27E)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77338-007-04	118.2 g in 1 TUBE; Type 0: Not a Combination Product	03/12/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	03/12/2024

Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)