NDC 0132-0301 Fleet

Mineral Oil

NDC Product Code 0132-0301

NDC 0132-0301-40

Package Description: 133 mL in 1 BOTTLE, WITH APPLICATOR

NDC Product Information

Fleet with NDC 0132-0301 is a a human over the counter drug product labeled by C.b. Fleet Company, Inc.. The generic name of Fleet is mineral oil. The product's dosage form is enema and is administered via rectal form.

Labeler Name: C.b. Fleet Company, Inc.

Dosage Form: Enema - A rectal preparation for therapeutic, diagnostic, or nutritive purposes.

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.

Fleet 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.

  • MINERAL OIL 100 g/100mL

Administration Route(s)

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

  • Rectal - Administration to the rectum.

Product Labeler Information

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

Labeler Name: C.b. Fleet Company, Inc.
Labeler Code: 0132
FDA Application Number: part334 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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 05-01-2002 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".

* Please review the disclaimer below.

Fleet 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

Active Ingredient

(in each 118-mL delivered dose)Mineral Oil 100%, Lubricant Laxative

Uses

  • For relief of fecal impactionfor relief of occasional constipationfor removal of residue after barium administration

Warnings

For rectal use onlyIf pregnant or breast-feeding ask a health professional before use.

Ask A Doctor Before Using Any Laxative If You Have

  • Abdominal pain, nausea or vomitinga sudden change in bowel habits lasting more than 2 weeksalready used a laxative for more than 1 weekIf constipation continues after one week of use, contact your doctor

Stop Use And Ask A Doctor If You Have

  • Rectal bleedingno bowel movement within 15 minutes of using this productThese symptoms may indicate a serious condition.

Keep Out Of Reach Of Children

Keep out of reach of children to prevent accidental ingestion.If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Single daily dose adults and children 12 years and over 1 bottle per day children 2 to under 12 years one-half bottle children under 2 yearsDO NOT USE

Other Information

  • Sodium freethis product generally produces a bowel movement in 2-15 minutesBOTTLE SEALED FOR SAFETY. IF BOTTLE WRAPPER WITH FLEET EMBLEM IS TORN, DAMAGED OR MISSING, DO NOT USE.for complete professional use warnings and precautions, consult the Reference Safety Information on our website

Questions?

1-866-255-6960 or www.fleetlabs.com

* Please review the disclaimer below.