ICY HOT ORIGINAL FOAM- menthol liquid

Icy Hot Original Foam by

Drug Labeling and Warnings

Icy Hot Original Foam by is a Otc medication manufactured, distributed, or labeled by Chattem, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

ICY HOT FOAM

(MENTHOL 16%)

Drug Facts

Active ingredient

Purpose

Menthol 16%......................................................................................................................................Topical analgesic

Uses

for the temporary relief of minor aches and pains of muscles and joints associated with:

■ arthritis    ■ simple backache    ■ strains    ■ sprains ■ bruises

Warnings

For external use only    

Flammable

■ keep away from heat and open flame

Do not use

■ on wounds, damaged, broken or irritated skin

■ with a heating pad

When using this product

■ use only as directed

■ do not bandage tightly

■ do not expose the area to local heat or to direct sunlight

■ rare cases of serious burns have been reported with products of this type

■ a transient burning sensation may occur upon application but generally disappears in several days

■ avoid contact with the eyes and mucous membranes

Stop use and ask a doctor if

■ condition worsens or symptoms persist for more than 7 days

■ symptoms clear up and occur again within a few days

■ severe burning sensation, redness or irritation develop

■ experience signs of skin injury, such as pain, swelling or blistering where the product was applied

If pregnant or breast-feeding,

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

adults and children 12 years of age and older:

■ pump slowly and apply to the affected area not more than 3 to 4 times daily

■ wash hands thoroughly with soap and water after each use

children under 12 years of age:  consult a doctor

Inactive ingredients

alcohol denat. (50%), bis-PEG-8 dimethicone, bis-PEG-12 dimethicone, propylene glycol, water

PRINCIPAL DISPLAY PANEL

ICY HOT
ORIGINAL
PAIN RELIEF
FOAM
MENTHOL 16%
4 FL OZ (118 mL)

INGREDIENTS AND APPEARANCE

ICY HOT ORIGINAL FOAM 
menthol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-0090
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	140.8 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALCOHOL (UNII: 3K9958V90M)
BIS-PEG-12 DIMETHICONE (500 MPA.S) (UNII: 2CNS542YRT)
PEG-8 DIMETHICONE (UNII: GIA7T764OD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-0090-1	118 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	01/15/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	01/15/2021

Labeler - Chattem, Inc. (003336013)