LEADER VAPOR STEAM (re-listed)

Leader Vapor Steam camphor (synthetic) by

Drug Labeling and Warnings

Leader Vapor Steam camphor (synthetic) by is a Otc medication manufactured, distributed, or labeled by CARDINAL HEALTH, Weeks & Leo Co., Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

LEADER VAPOR STEAM CAMPHOR (SYNTHETIC)- camphor (synthetic) liquid 
CARDINAL HEALTH

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.

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LEADER VAPOR STEAM (re-listed)

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.

If pregnant or breast-feeding,

ask a health professional before use.

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

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 - 8oz

CAUTION: NOT FOR INTERNAL USE

NDC: 70000-0563-1

LEADER

Vapor Steam

Camphor,6.2%

Cough Suppressant

Liquid Medication For Hot Steam Vaporizers

Temporarily Relieves Steam

Soothing Menthol Scent

Compare Vicks® Vapo Steam active ingredient*

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8 fl oz (237 mL)

LEADER VAPOR STEAM CAMPHOR (SYNTHETIC) 
camphor (synthetic) liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0563
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
NUTMEG OIL (UNII: Z1CLM48948)
POLOXAMER 124 (UNII: 1S66E28KXA)
LAURETH-7 (UNII: Z95S6G8201)
DIMETHICONE (UNII: 92RU3N3Y1O)
MENTHOL (UNII: L7T10EIP3A)
CEDAR LEAF OIL (UNII: BJ169U4NLG)
ALCOHOL (UNII: 3K9958V90M)
EUCALYPTUS OIL (UNII: 2R04ONI662)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0563-8	237 in 1 CARTON	09/02/2020
1		237 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	M012	09/02/2020	03/14/2023

Labeler - CARDINAL HEALTH (063997360)

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

Establishment
Name	Address	ID/FEI	Business Operations
Weeks & Leo Co., Inc.		005290028	manufacture(70000-0563)

Revised: 3/2023

Document Id: f6e027e8-6984-45fd-e053-6394a90ad9e9

34390-5

Set id: f445f42b-542b-cd81-e053-2a95a90ac3bd

Version: 3

Effective Time: 20230314