ICE GEL ICE COLD ANALGESIC- menthol gel

Drug Labeling and Warnings

Drug Details [pdf]

Active ingredient

Menthol 1.25%

Purpose

Topical Analgesic

Uses

■ temporarily relieves minoraches and pains of muscles and joints associated with:

■ arthritis ■ simple backache ■ strains ■ bruises ■ sports injuries ■ sprains ■ ​provides cooling penetrating relief

Warnings

For external use only

Do not use

■ with other topical relievers ■ with heating pads or heating devices

When using this product

■ do not use in or near the 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

Keep out of reach of children

If pregnant or breast-feeding,ask a health professional before use. 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 ■ children under 2 years of age: ask a doctor

Other information

■ stroe at controlled room temperature 20 to 25 ºC (68 to 77ºF) in a tightly closed container ■ do not use, pour, spill or store near heat or open flame

Inactive Ingredients

benzyl alcohol, BHT, camphor, carbopol, disodium EDTA, FD&C blue no. 1, isopropyl alcohol, PEG-40 hydrogenated castor oi, propylene glycol, sodium hydroxide, water

Package Label

INGREDIENTS AND APPEARANCE

ICE GEL  ICE COLD ANALGESIC
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52000-220
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1.25 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52000-220-01	227 g in 1 JAR; Type 0: Not a Combination Product	04/02/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	04/02/2018

Labeler - Universal Distribution Center LLC (019180459)

Registrant - Jell Pharmaceuticals Pvt Ltd (726025211)

Establishment
Name	Address	ID/FEI	Business Operations
Jell Pharmaceuticals Pvt Ltd		726025211	manufacture(52000-220)