LEADER VAPOR STEAM CAMPHOR (SYNTHETIC)- camphor (synthetic) liquid 
LEADER/Cardinal Health 110, Inc.

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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 DrugM01209/02/2020
Labeler - LEADER/Cardinal Health 110, Inc. (063997360)
Registrant - Weeks & Leo Co., Inc. (005290028)
Establishment
NameAddressID/FEIBusiness Operations
Weeks & Leo Co., Inc.005290028manufacture(70000-0563)

Revised: 1/2024
Document Id: 0eb1de79-7e0e-0d59-e063-6394a90add5a
Set id: ae580e6c-2efd-c788-e053-2995a90a3360
Version: 4
Effective Time: 20240111
 
LEADER/Cardinal Health 110, Inc.