NDC 49035-099 Vaporizing

Camphor

NDC Product Code 49035-099

NDC 49035-099-34

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

NDC Product Information

Vaporizing with NDC 49035-099 is a a human over the counter drug product labeled by Wal-mart Stores, Inc. The generic name of Vaporizing is camphor. The product's dosage form is inhalant and is administered via respiratory (inhalation) form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 701961.

Dosage Form: Inhalant - A special class of inhalations consisting of a drug or combination of drugs, that by virtue of their high vapor pressure can be carried by an air current into the nasal passage where they exert their effect; the container from which the inhalant generally is administered is known as an inhaler.

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.

Vaporizing 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.


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.

  • ALCOHOL (UNII: 3K9958V90M)
  • CEDAR LEAF OIL (UNII: BJ169U4NLG)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • LAURETH-7 (UNII: Z95S6G8201)
  • MENTHOL (UNII: L7T10EIP3A)
  • NUTMEG OIL (UNII: Z1CLM48948)
  • POLOXAMER 124 (UNII: 1S66E28KXA)

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.

Product Labeler Information

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

Labeler Name: Wal-mart Stores, Inc
Labeler Code: 49035
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: 03-07-2014 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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Vaporizing Product Label Images

Vaporizing 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

Safety Information

CAUTION: NOT FOR INTERNAL USE.  Do not use if printed seal under cap is broken or missing.  Failure to follow these warnings could result in serious consequences.

Active Ingredient

Camphor 6.2%

Purpose

Cough suppressant

Use

Use temporarily relieves cough associated with a cold

Warnings

For external use onlyFor steam inhalation only. Do not take by mouth.

Flammable

  • Keep away from fire or flame.

Ask A Doctor Before Use If You Have

  • A persistent or chronic cough such as occurs with smoking, emphsema or asthmaa cough that occurs with too much phlegm ( mucus)

When Using This Product Do Not

  • Heatmicrowaveuse near an open flameadd 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

Cough persists for more than 1 week, tends to recur or is accompanied by fever, rash or persisten headach.  A persistent cough may be a sign of a serious condition.

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • See important warnings under "When using this product"adults & children 2 years and older: use 1 tablespoon of solution for each quart of water or 1 1/2 teaspoons of sulution for each pint of wateradd solution directly to cold water only in a hot steam vaporizerfollow manufacturer's directions for using vaporizerbreath in medicated vaporsmay be repeated up to 3 times a daychildren under 2 years: ask a doctor

Other Information

  • Close container tightly and store at room temperature away from heat

Inactive Ingredients

Alcohol 84%, cedarleaf oil, dimethicone, eucalyptus oil, laureth-7, menthol, nutmeg oil, poloxamer 124

Questions?

1-888-287-1915

Guarantee Claim

Satisfaction guaranteed-For questions or comments please call 1-888-287-1915

Disclaimer

This product is not manufactured or distributed by Procter + Gamble, owner of the registered trademark Vicks Vapo Steam

Adverse Reactions Section

Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716

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