ASTONEA COLD ICE ANALGESIC GEL- menthol gel
ASTONEA LABS PRIVATE LIMITED

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Astonea Cold Ice Gel

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 and Drug Fact Panel

ASTONEA COLD ICE ANALGESIC GEL
menthol gel

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	04/08/2019

Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)