Quality Choice Vapor Steam (Camphor (Synthetic)) Liquid [Chain Drug Marketing Association, Inc.] -

QUALITY CHOICE VAPOR STEAM (CAMPHOR (SYNTHETIC)) LIQUID [CHAIN DRUG MARKETING ASSOCIATION, INC.]
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NDC	63868-111-04
Set ID	8722a545-e3e3-7457-e053-2991aa0aed60
Category	HUMAN OTC DRUG LABEL
Packager	Chain Drug Marketing Association, Inc.
Generic Name
Product Class
Product Number
Application Number	PART341

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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

Quality Choice

Compare to the active ingredient in Vicks ® VapoSteam ®*

MEDICATED VAPORIZING STEAM LIQUID

COUGH SUPPRESSANT CONTAINS CAMPHOR

Liquid Medication for Hot Steam Vaporizers

Relieves Cough to Help You Rest

CAUTION: NOT FOR INTERNAL USE

INGREDIENTS AND APPEARANCE

QUALITY CHOICE VAPOR STEAM
camphor (synthetic) liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63868-111
Route of Administration	RESPIRATORY (INHALATION)

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	0.623 g in 10 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63868-111-04	1 in 1 CARTON	07/01/2014
1		118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	11/02/2011

Labeler - Chain Drug Marketing Association, Inc. (011920774)

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

Name	Address	ID/FEI	Business Operations
Establishment
Weeks & Leo Co., Inc.		005290028	manufacture(63868-111)

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Medic

Ask a doctor before use if you have

When using this product, do not

Keep out of reach of children.