ASTONEA COLD ICE ANALGESIC GEL- menthol gel

ASTONEA Cold Ice Analgesic Gel by

Drug Labeling and Warnings

ASTONEA Cold Ice Analgesic Gel 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 2.0%

Purpose

Topical Analgesic

Uses:

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

Warnings

FOR EXTERNAL USE ONLY

Do not use:

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

When using this product

• 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

• 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

ask a health professional before use

KEEP OUT OF REACH OF CHILDREN

If swallowed get Medical Help or contact a Poison Control Center right away

Directions

• 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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ASTONEA COLD ICE ANALGESIC GEL 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77338-402
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	4.54 g  in 227 g

Inactive Ingredients
Ingredient Name	Strength
AMMONIA (UNII: 5138Q19F1X)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
CUPRIC SULFATE (UNII: LRX7AJ16DT)
THYMOL (UNII: 3J50XA376E)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77338-402-12	227 g in 1 JAR; Type 0: Not a Combination Product	04/08/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	04/08/2019

Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)