ICY HOT NO MESS VAPOR COUGH SUPPRESANT- camphor and eucalyptus oil and menthol gel
Chattem, 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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Icy Hot No Mess Vapor Gel Cough Suppresant

Drug Facts

Active Ingredients

Camphor 5.3%
Eucalyptus oil 1.3%
Menthol 2.8%

Purpose

Cough suppressant

Use

on chest and throat, temporarily relieves cough due to the common cold

Warnings

For external use only

When using this product do not

take this product for persistent or chronic cough such as occurs with smoking, asthma, emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor
take by mouth
place in nostrils
heat
microwave
add to hot water or any container where heating water. May cause splattering and result in burns.

Stop use and ask a doctor if

cough persists for more than one week, tends to recur, or is accompanied by fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.

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

See important warnings under “When using this product do not”

adults and children 2 years and older:

squeeze desired amount of gel onto upper chest and/or throat as a thick layer
using the sponge-top applicator, gently massage dispensed gel into skin until thoroughly absorbed
cover with a warm, dry cloth if desired
clothing should be left loose about the throat and chest to help the vapors reach the nose and mouth
use up to 3 times daily or as directed by doctor

children under 2 years of age: ask a doctor

Inactive ingredients

cyclomethicone, dimethicone, glyceryl stearate, PEG-12 dimethicone, petrolatum, polyethylene, silica (283-083)

PRINCIPAL DISPLAY PANEL

ICYHOT®
NO-MESS
VAPOR GEL
COUGH SUPPRESSANT
NET WT 2 OZ (56 G)

PRINCIPAL DISPLAY PANEL
ICY HOT NO-MESS VAPOR GEL

ICY HOT NO MESS VAPOR COUGH SUPPRESANT
camphor and eucalyptus oil and menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41167-0094
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	5.3 g in 100 g
EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662)	EUCALYPTUS OIL	1.3 g in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	2.8 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
CYCLOMETHICONE (UNII: NMQ347994Z)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PETROLATUM (UNII: 4T6H12BN9U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:41167-0094-0	1 in 1 CARTON	06/10/2010	06/01/2012
1		56 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part341	06/10/2010	06/01/2012

Labeler - Chattem, Inc. (003336013)

Name	Address	ID/FEI	Business Operations
Establishment
Chattem Plant 2		830410721	MANUFACTURE(41167-0094)

Revised: 6/2012

Document Id: c7647f21-05d6-4593-86d0-55af4e339831

Set id: 7fcd218c-39ea-4121-87a7-f7296c1e2c5a

Version: 2

Effective Time: 20120601

Chattem, Inc.