ASTONEA COLD THERAPY- menthol 4% gel 
ASTONEA LABS PRIVATE LIMITED

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ASTONEA COLD THERAPY 4% MENTHOL

Menthol 4%

Topical Analgesic

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

arthritis

backache

strains

sprains

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)

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

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 and Drug Fact Panel

ASTONEA COLD THERAPY 
menthol 4% gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77338-007
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77338-007-04118.2 g in 1 TUBE; Type 0: Not a Combination Product03/12/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01703/12/2024
Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)

Revised: 3/2024
Document Id: 137cfc8f-c027-022a-e063-6394a90ac727
Set id: 137cec16-20e9-ab5c-e063-6294a90a11db
Version: 1
Effective Time: 20240312
 
ASTONEA LABS PRIVATE LIMITED