Icy Hot No Mess Vapor Gel Cough Suppresant for Kids

Drug Labeling and Warnings

Drug Details [pdf]

ICY HOT NO MESS VAPOR COUGH SUPPRESANT FOR KIDS- 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 for Kids

Drug Facts

Active Ingredients

Camphor 4.7
Eucalyptus oil 1.2%
Menthol 2.6%

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

• give 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
for
Kids
COUGH SUPPRESSANT
NET WT 2 OZ (56 G)

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-0096
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	4.7 g  in 100 g
EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662)	EUCALYPTUS OIL	1.2 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	2.6 g  in 100 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-0096-0	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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	06/10/2010	06/01/2012

Labeler - Chattem, Inc. (003336013)

Establishment
Name	Address	ID/FEI	Business Operations
Chattem Plant 2		830410721	MANUFACTURE(41167-0096)

Revised: 6/2012

Document Id: bac32c03-39c8-4e44-aa3f-ddaad4f8ed86

34390-5

Set id: 9169862a-9fed-4d88-b17d-0a1a7a5c9690

Version: 2

Effective Time: 20120601

 

Chattem, Inc.