FDA.reportPublic FDA data

Leader Vapor Steam camphor (synthetic)

Manufacturer
CARDINAL HEALTH | Weeks & Leo Co., Inc.
Effective date
2023-02-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:37:04

Label at a glance#

ProductLeader Vapor Steam camphor (synthetic)
Active ingredientCAMPHOR (SYNTHETIC)
Label structure10 sections

Dosage and administration

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...

Storage and handling

close container tightly and store at room temperature away from heat

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Camphor 6.2%

Purpose

OTC - PURPOSE SECTION

Cough suppressant

Use

INDICATIONS & USAGE SECTION

temporarily relieves cough ocurring with a cold

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

For external use only.
Flammable: Keep away from fire or flame.
For steam inhalation only.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • 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

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

close container tightly and store at room temperature away from heat

Inactive ingredients

INACTIVE INGREDIENT SECTION

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 - 8oz

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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*

100% Money Back Guarantee

8 fl oz (237 mL)

Leader Vapor SteamLeader Vapor Steam

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0563-1ML - Milliliter70000-05633979cb81-ba03-4122-bb26-3f4f2c46fc7f12021-02-05

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-056370000-0563-8

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
NUTMEG OILZ1CLM48948IACT
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
POLOXAMER 1241S66E28KXAIACT
LAURETH-7Z95S6G8201IACT
DIMETHICONE92RU3N3Y1OIACT
MENTHOLL7T10EIP3AIACT
CEDAR LEAF OILBJ169U4NLGIACT
ALCOHOL3K9958V90MIACT
EUCALYPTUS OIL2R04ONI662IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Vapor Steam camphor (synthetic)CAMPHOR (SYNTHETIC)LEADER/Cardinal Health 110, Inc.ae580e6c-2efd-c788-e053-2995a90a33602024-12-19WarningsExact identifier
ndc (product): 70000-0563
f6e027e8-6984-45fd-e053-6394a90ad9e9f445f42b-542b-cd81-e053-2a95a90ac3bd2023-03-14WarningsExact identifier
spl set id: f445f42b-542b-cd81-e053-2a95a90ac3bd

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.