Label: CAMPHOR, EUCALYPTUS OIL AND MENTHOL ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 59779-717-01 - Packager: CVS
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated February 14, 2011
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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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
- INDICATIONS & USAGE
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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.
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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
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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
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INGREDIENTS AND APPEARANCE
CAMPHOR, EUCALYPTUS OIL AND MENTHOL
camphor, eucalyptus oil and menthol ointmentProduct 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