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)

PRINCIPAL DISPLAY PANEL
ICY HOT NO-MESS VAPOR GEL FOR KIDS

ICY HOT NO MESS VAPOR COUGH SUPPRESANT FOR KIDS 
camphor and eucalyptus oil and menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 41167-0096
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
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 OIL1.2 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.6 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE (UNII: NMQ347994Z)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PETROLATUM (UNII: 4T6H12BN9U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 41167-0096-01 in 1 CARTON06/10/201006/01/2012
156 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34106/10/201006/01/2012
Labeler - Chattem, Inc. (003336013)
Establishment
NameAddressID/FEIBusiness Operations
Chattem Plant 2830410721MANUFACTURE(41167-0096)

Revised: 6/2012
 
Chattem, Inc.