ICY HOT - menthol and methyl salicylate stick
H.J. Harkins Company, Inc.

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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ICYHOT® PAIN RELIEVING STICK
Drug Facts

Active ingredient

Menthol 10%

Methyl salicylate 30%

Purpose

Topical analgesic

Uses

temporarily relieves minor pain associated with:

arthritis
simple backache
muscle strains
sprains
bruises
cramps

Warnings

For external use only

SEE INSIDE LABEL FOR COMPLETE DRUG FACTS

Allergy Alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

When using this product

use only as directed
do not bandage tightly or use with a heating pad
avoid contact with eyes or mucous membranes
do not apply to wounds or damaged, broken or irritated skin

Stop use and ask a doctor if

condition worsens
redness is present
irritation develops
symptoms persist for more than 7 days or clear up and occur again within a few days

If pregnant or breast-feeding,

ask a health care 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 over 12 years:

apply generously to affected area
massage into painful area until thoroughly absorbed into skin
repeat as necessary, but not more than 4 times daily

children 12 years or younger: ask a doctor

Inactive ingredients

ceresin, cyclomethicone, hydrogenated castor oil, microcrystalline wax, paraffin, PEG-150 distearate, propylene glycol, stearic acid, stearyl alcohol (245-111)

Repacked by:
H.J. Harkins Company, Inc.
513 Sandydale
Nipomo, CA 93444

LABEL

ICY HOT
menthol and methyl salicylate stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52959-028(NDC:41167-0089)
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (MENTHOL)	MENTHOL	10 g in 100 g
METHYL SALICYLATE (METHYL SALICYLATE)	METHYL SALICYLATE	30 g in 100 g

Inactive Ingredients
Ingredient Name	Strength
CERESIN
CYCLOMETHICONE
HYDROGENATED CASTOR OIL
MICROCRYSTALLINE WAX
PARAFFIN
PEG-150 DISTEARATE
PROPYLENE GLYCOL
STEARIC ACID
STEARYL ALCOHOL

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:52959-028-03	49 g in 1 JAR	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	06/01/1991

Labeler - H.J. Harkins Company, Inc. (147681894)

Establishment
Name	Address	ID/FEI	Operations
Chattem Plant 1		003336013	MANUFACTURE

Establishment
Name	Address	ID/FEI	Operations
Chattem Plant 2		830410721	MANUFACTURE

Revised: 08/2011 H.J. Harkins Company, Inc.