CAMPHOR, EUCALYPTUS OIL AND MENTHOL - camphor, eucalyptus oil and menthol ointment 
CVS

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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drug facts

Active ingredient                            Purpose

Camphor 5.2%.............................Cough Suppressant and topical analgesic
Eucalyptus oil 1.2%......................Cough Suppressant
Menthol2.8%................................Cough Suppressant and topical analgesic


Active ingredient                     Purpose

Camphor 5.2%.............................Cough Suppressant and topical analgesic
Eucalyptus oil 1.2%......................Cough Suppressant
Menthol2.8%................................Cough Suppressant and topical analgesic

Uses
 
- on chest and throat, temporarily relieves cough due to common cold
- On muscles and joints, temporarily relieves minor aches and pains


Keep out of reach of children. If swallowed, get
medical help or contact a Poison Control Center right away.


Uses - temporarily relieves cough due to minor throat
and bronchial irritation associated with a cold.

Warnings

For external use only; avoid contact with the eyes.

Do not use

- by mouth - with tight bandages - in nostrils - on wounds or damaged skin

Ask a doctor before use if you have

- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma or emphysema.

When using this product, do not

- 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

-muscle aches and pains persist for more than 7 days or come back
- cough lasts for more than 7 days, comes back or occurs with fever, rash or
persistent headache. These could be signs of a serious condition.

If pregnant or breast feeding, ask a 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"

- Adults and children 2 years and older:

- rub a thick layer on chest and throat or rub on sore aching muscles
- cover with a warm, dry cloth if desired
- keep clothing loose about throat/chest to help vapors reach the nose/mouth
- repeat up to three times per 24 hours or as directed by a doctor.

Children under 2 years of age" ask a doctor.

Other Information

store at room temperature


Inactive Ingredients


Carbomer 954, cedarleaf oil, cetyl alcohol,
cetyl palmitate, cyclomethicone copolyol,
dimethicone copolyol, dimethicone, ETDA,
glycerin, imidazolidinyl urea, isopropyl palmitate,
methylparaben, nutmeg oil, PEG-100 stearate,
propylparaben, purified water, sodium hydroxide,
stearic acid, thymol, titanium dioxide,
turpentine oil

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CAMPHOR, EUCALYPTUS OIL AND MENTHOL 
camphor, eucalyptus oil and menthol ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-717
Route of AdministrationRESPIRATORY (INHALATION)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)52 mg  in 1 mL
EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL12 mg  in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL28 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CARBOMER 934 (UNII: Z135WT9208)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CEDAR LEAF OIL (UNII: BJ169U4NLG)  
CETYL PALMITATE (UNII: 5ZA2S6B08X)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
NUTMEG OIL (UNII: Z1CLM48948)  
POLYOXYL 100 STEARATE (UNII: YD01N1999R)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
THYMOL (UNII: 3J50XA376E)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TURPENTINE (UNII: XJ6RUH0O4G)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-717-011 in 1 CARTON
1237 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/19/2009
Labeler - CVS (062312574)
Registrant - Pharma Pac, LLC (140807475)
Establishment
NameAddressID/FEIBusiness Operations
Pharma Pac, LLC140807475manufacture

Revised: 2/2011
Document Id: e3aac781-4648-4350-b0d5-33309d6519cb
Set id: c4d08cc6-e424-40ae-9c9b-5d5b1619377a
Version: 1
Effective Time: 20110214
 
CVS