CAMPHOR, EUCALYPTUS OIL AND MENTHOL ointment

CAMPHOR, EUCALYPTUS OIL and MENTHOL by

Drug Labeling and Warnings

CAMPHOR, EUCALYPTUS OIL and MENTHOL by is a Otc medication manufactured, distributed, or labeled by CVS, Pharma Pac, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                            Purpose

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

PURPOSE

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

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

INDICATIONS & USAGE

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

WARNINGS

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.

DOSAGE & ADMINISTRATION

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 INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-717
Route of Administration	RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	52 mg  in 1 mL
EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662)	EUCALYPTUS OIL	12 mg  in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	28 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59779-717-01	1 in 1 CARTON
1		237 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/19/2009

Labeler - CVS (062312574)

Registrant - Pharma Pac, LLC (140807475)

Establishment
Name	Address	ID/FEI	Business Operations
Pharma Pac, LLC		140807475	manufacture