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 (relisted)

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

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

LEADER VAPOR STEAM CAMPHOR (SYNTHETIC) 
camphor (synthetic) liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0563
Route of AdministrationRESPIRATORY (INHALATION)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)0.062 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0563-11 in 1 CARTON09/02/2020
1237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM01209/02/2020
Labeler - CARDINAL HEALTH (063997360)
Registrant - Weeks & Leo Co., Inc. (005290028)
Establishment
NameAddressID/FEIBusiness Operations
Weeks & Leo Co., Inc.005290028manufacture(70000-0563)

Revised: 3/2023
Document Id: f67e348f-d471-98ff-e053-2995a90a0af4
Set id: ae580e6c-2efd-c788-e053-2995a90a3360
Version: 3
Effective Time: 20230309
 
CARDINAL HEALTH