NDC 70000-0563 Leader Vapor Steam Camphor (synthetic)

Camphor (synthetic)

NDC Product Code 70000-0563

NDC 70000-0563-1

Package Description: 1 BOTTLE, PLASTIC in 1 CARTON > 237 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Leader Vapor Steam Camphor (synthetic) with NDC 70000-0563 is a a human over the counter drug product labeled by Cardinal Health. The generic name of Leader Vapor Steam Camphor (synthetic) is camphor (synthetic). The product's dosage form is liquid and is administered via respiratory (inhalation) form.

Labeler Name: Cardinal Health

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Leader Vapor Steam Camphor (synthetic) Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • CAMPHOR (SYNTHETIC) .062 g/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • 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)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.
  • Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Cardinal Health
Labeler Code: 70000
FDA Application Number: part341 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 09-02-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Leader Vapor Steam Camphor (synthetic) Product Label Images

Leader Vapor Steam Camphor (synthetic) Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Drug Facts

Tamper-evident: do not use if the imprinted seal under the cap is broken or missing.
Keep this carton. It has important information.

Active Ingredient

Camphor 6.2%

Purpose

Cough suppressant

Use

Temporarily relieves cough ocurring with a cold

Otc - Do Not Use

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

  • Heatmicrowaveuse near an open flametake by mouthdirect steam from the vaporizer too close to the faceadd 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

  • 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 wateradd solution directly to cold water only in a hot steam vaporizerfollow manufacturer's directions for using vaporizerbreathe in the medicated vaporsuse up to three times daily or as directed by a doctorchildren under 2 years: ask a doctor

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

* Please review the disclaimer below.