HOT ICE SOOTHING ANALGESIC GEL- menthol gel

Hot Ice Soothing Analgesic Gel by

Drug Labeling and Warnings

Hot Ice Soothing Analgesic Gel by is a Otc medication manufactured, distributed, or labeled by Kim Chemicals LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Active Ingredients 

Menthol             1.0%

Purpose

Topical Analgesic

Uses

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

Warnings

For external use only. Not for internal use.

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.

It 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. If you have sensitive skin, 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 spill near heat or open flame. Store in a cool, dry place and keep lid tightly closed.

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 of age.

Other Ingredients

Water, Isopropyl Alcohol, Nonoxynol-10, Camphor, Carbomer, Sodium Hydroxide, Methylchloroisothiazolinone & Methylisothiazolinone, Blue 1

Principal Display Panel

Perfect Purity

HotIce

Soothing analgesic gel

Fast, temporary relief from muscle aches and pains

• greaseless
  
• analgesic

NET WT. 8 OZ. (227 g)

INGREDIENTS AND APPEARANCE

HOT ICE SOOTHING ANALGESIC GEL 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 34954-013
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
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
CAMPHOR (UNII: 5TJD82A1ET)
CARBOMER 934 (UNII: Z135WT9208)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 34954-013-07	227 g in 1 JAR

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

Labeler - Kim Chemicals LTD (650470164)