Label: LEADER VAPOR STEAM CAMPHOR (SYNTHETIC) (camphor- synthetic liquid
- NDC Code(s): 70000-0563-1
- Packager: LEADER/Cardinal Health 110, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 11, 2024
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
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Warnings
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.
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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
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 8oz
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INGREDIENTS AND APPEARANCE
LEADER VAPOR STEAM CAMPHOR (SYNTHETIC)
camphor (synthetic) liquidProduct 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:70000-0563-1 1 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 Drug M012 09/02/2020 Labeler - LEADER/Cardinal Health 110, Inc. (063997360) Registrant - Weeks & Leo Co., Inc. (005290028) Establishment Name Address ID/FEI Business Operations Weeks & Leo Co., Inc. 005290028 manufacture(70000-0563)