WEEKS AND LEO MEDICATED VAPORIZING STEAM (camphor- synthetic liquid

Weeks and Leo Medicated Vaporizing Steam by

Drug Labeling and Warnings

Weeks and Leo Medicated Vaporizing Steam by is a Otc medication manufactured, distributed, or labeled by Weeks & Leo Co., Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Camphor 6.2%

Purpose

Cough suppressant

Use

temporarily relieves cough ocurring with a cold

Warnings

For external use only.

Flammable. Keep away from fire or flame.

For steam inhalation only.

Ask a doctor before use if you have

a cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema

cough that ocurs with too much phlegm (mucus)

When using this product, do not

• heat
• microwave
• use near an open flame
• take by mouth
• 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 lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. In case of eye exposure, flush with water.

Directions

• see important warnings under "When using this product"
• adults & children 2 years & over:
• use 1 tablespoon of solution for each quart of water or 1½ teaspoonful of solution for 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: ask a doctor

Other information

• close container tightly and store at room temperature away from heat

Inactive ingredients

alcohol (78%), cedarleaf oil, dimethicone, eucalyptus oil, laureth-7, menthol, nutmeg oil, poloxamer 124

SPL UNCLASSIFIED SECTION

Tamper-evident: do not use if the imprinted seal under the cap is broken or missing.

Keep this carton. It has important information.

PRINCIPAL DISPLAY PANEL - 4oz

CAUTION: NOT FOR INTERNAL USE

NDC: 11383-256-04

WEEKS&LEO

Medicated VAPORIZING STEAM LIQUID

Relieves Cough to Help You Rest

Liquid Medication For Hot Steam Vaporizers

Cough Suppressant

Contains Camphor

Compare Vicks ® Vapo Steam active ingredient*

4 fl oz (118 mL)

INGREDIENTS AND APPEARANCE

WEEKS AND LEO MEDICATED VAPORIZING STEAM 
camphor (synthetic) liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11383-256
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)	0.623 g  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
CEDAR LEAF OIL (UNII: BJ169U4NLG)
EUCALYPTUS OIL (UNII: 2R04ONI662)
LAURETH-7 (UNII: Z95S6G8201)
MENTHOL (UNII: L7T10EIP3A)
NUTMEG OIL (UNII: Z1CLM48948)
POLOXAMER 124 (UNII: 1S66E28KXA)
DIMETHICONE (UNII: 92RU3N3Y1O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11383-256-08	1 in 1 CARTON	07/01/2014
1		236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 11383-256-04	1 in 1 CARTON	07/01/2014
2		118 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	11/02/2011

Labeler - Weeks & Leo Co., Inc. (005290028)

Registrant - Weeks & Leo Co., Inc. (005290028)

Establishment
Name	Address	ID/FEI	Business Operations
Weeks & Leo Co., Inc.		005290028	manufacture(11383-256)