Label: LEADER VAPOR STEAM CAMPHOR (SYNTHETIC) (camphor- synthetic liquid
- NDC Code(s): 70000-0563-1
- Packager: CARDINAL HEALTH
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated September 2, 2020
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- SPL UNCLASSIFIED SECTION
- Active ingredient
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
- 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.
- 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
INGREDIENTS AND APPEARANCE
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:70000-0563-1 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 final part341 09/02/2020 Labeler - CARDINAL HEALTH (097537435) Registrant - Weeks & Leo Co., Inc. (005290028) Establishment Name Address ID/FEI Business Operations Weeks & Leo Co., Inc. 005290028 manufacture(70000-0563)