Icy Hot No Mess Vapor Cough Suppresant

Dosage form: gel
Ingredients: CAMPHOR (SYNTHETIC) 5.3g in 100g, EUCALYPTUS OIL 1.3g in 100g, MENTHOL 2.8g in 100g
Labeler: Chattem, Inc.
NDC Code: 41167-0094

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.

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)

ICY HOT NO MESS VAPOR COUGH SUPPRESANT 
camphor and eucalyptus oil and menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0094
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC)5.3 g  in 100 g
EUCALYPTUS OIL (EUCALYPTUS OIL) EUCALYPTUS OIL1.3 g  in 100 g
MENTHOL (MENTHOL) MENTHOL2.8 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE 
DIMETHICONE 
GLYCERYL MONOSTEARATE 
PETROLATUM 
SILICON DIOXIDE 
Packaging
#Item CodePackage Description
1NDC:41167-0094-01 TUBE, WITH APPLICATOR (1 TUBE) in 1 CARTON
156 g in 1 TUBE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34106/10/2010
Labeler - Chattem, Inc. (003336013)
Establishment
NameAddressID/FEIOperations
Chattem Plant 2830410721MANUFACTURE

Revised: 08/2010
 
Chattem, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web5)