COOL HOT ICE ANALGESIC GEL- menthol gel

Cool Hot Ice Analgesic Gel by

Drug Labeling and Warnings

Cool Hot Ice Analgesic Gel by is a Otc medication manufactured, distributed, or labeled by SHIELD LINE LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Menthol 1.0%

Purpose

Topical Analgesic

Uses:

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

Warnings

FOR EXTERNAL USE ONLY

Use only as directed. Avoid contact with eyes or mucous membranes. Do not apply to open wounds or damaged skin. Make sure skin is clean and free from any creams , ointments , sprays or liniment. Do not bandage.

Do not use with heating pads or heating devices

If condition worsens or symptoms persist for more than 7 days, or if symptoms disappear and occur again within a few days, discontinue use and consult a physician before use. If skin irritation develops, discontinue use and consult a physician. If you are pregnant or nursing a baby, consult your doctor before use. Do not use, store, pour or spoll near heat or open flame. Store in a cool, dry place and keep lid tightly closed.

KEEP OUT OF REACH OF CHILDREN

In case of accidental ingestion, get medical help or contact a Poison Control Center right away

Directions

Clean skin of all other lotions, creams, ointments, liniment, or sprays. Apply liberally to affected area and massage until gel is absorbed into skin. Do not apply more than 3 or 4 times daily. No protective cover needed. Do not apply to children under 2 years or age.

Inactive Ingredients

Water, Isopropyl Alchohol , Nonoxynol-10, Camphor, Carbomer 934, Sodium Hydroxide, Methylchloroisothiazolinone & Methylisothiazolinone, FD&C Blue no. 1

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

COOL HOT ICE ANALGESIC GEL 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52410-0201
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	2.27 g  in 227 g

Inactive Ingredients
Ingredient Name	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302)
NONOXYNOL-10 (UNII: K7O76887AP)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
CARBOMER 934 (UNII: Z135WT9208)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52410-0201-2	227 g in 1 JAR; Type 0: Not a Combination Product	09/21/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	09/21/2009

Labeler - SHIELD LINE LLC (078518916)