VICKS VAPOSTEAM (camphor- synthetic liquid

Vicks VapoSteam by

Drug Labeling and Warnings

Vicks VapoSteam by is a Otc medication manufactured, distributed, or labeled by Kaz USA, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Camphor (Synthetic) 6.2%

Purpose

Cough suppressant

Use

temporarily relieves cough associated with a cold

Warnings

For external use only.

Flammable: Keep away from fire or flame. For steam inhalation only. Do not take by mouth.

Ask a doctor before use if you have

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

When using this product, do not

• heat
• microwave
• use near an open flame
• direct steam from the vaporizer too close to the face
• add to hot water or any container where heating water except when adding to cold water only in a hot steam vaporizer. May cause splattering and result in burns.

Stop use and ask a doctor if cough persists for more than 1 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. In case of eye exposure (flush eyes with water); or if swallowed, seek medical help or contact a Poison Control Center right away.

Directions

• see important warnings under "When using this product"
• adults & children 2 years & over:
  • add 1 tablespoon of solution to each quart of water or 1½ teaspoons of solution to each pint of water
  • add solution directly to cold water only in a hot steam vaporizer
  • follow manufacturer's directions for using vaporizer
  • breathe in the medicated vapors
  • use up to three times daily or as directed by a doctor
• children under 2 years: do not use

Other information

• close container tightly and store at room temperature away from heat
• contains 78% alcohol

Inactive ingredients

alcohol, cedarleaf oil, eucalyptus oil, laureth-7, menthol, nutmeg oil, poloxamer 124, silicone

Questions?

1-800-VAPOR-1-2 (1-800-827-6712)

SPL UNCLASSIFIED SECTION

Dist. by Kaz USA, Inc.,
Southborough, MA 01772

PRINCIPAL DISPLAY PANEL - 236 mL Bottle Carton

VICKS®

Vapo
Steam®

Camphor

COUGH SUPPRESSANT
FOR USE IN
HOT STEAM VAPORIZERS

• Produces Medicated Steam
  that Helps to Relieve Coughs

! DO NOT TAKE
BY MOUTH

8 FL OZ (236 ml)

INGREDIENTS AND APPEARANCE

VICKS VAPOSTEAM 
camphor (synthetic) liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69901-522
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)	0.062 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Alcohol (UNII: 3K9958V90M)
Menthol, Unspecified Form (UNII: L7T10EIP3A)
Poloxamer 124 (UNII: 1S66E28KXA)
Laureth-7 (UNII: Z95S6G8201)
Eucalyptus Oil (UNII: 2R04ONI662)
Cedar Leaf Oil (UNII: BJ169U4NLG)
Nutmeg Oil (UNII: Z1CLM48948)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69901-522-08	1 in 1 CARTON	02/28/1995
1		236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	02/28/1995

Labeler - Kaz USA, Inc (001483890)

Establishment
Name	Address	ID/FEI	Business Operations
Procter & Gamble Manufactura, S. de R.L. de C.V.		812807550	MANUFACTURE(69901-522)

Establishment
Name	Address	ID/FEI	Business Operations
Les Emballages Knowlton Inc		248704645	MANUFACTURE(69901-522)