NDC 0132-0705 Fleet

Mineral Oil And Witch Hazel

NDC Product Code 0132-0705

NDC 0132-0705-00

Package Description: 1 KIT in 1 CARTON * 2 BOTTLE, WITH APPLICATOR in 1 CARTON > 133 mL in 1 BOTTLE, WITH APPLICATOR * 2 CLOTH in 1 CARTON

NDC Product Information

Fleet with NDC 0132-0705 is a a human over the counter drug product labeled by C.b. Fleet Company, Inc.. The generic name of Fleet is mineral oil and witch hazel. The product's dosage form is kit and is administered via form.

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

Dosage Form: Kit - A packaged collection of related material.

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.

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.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • BRONOPOL (UNII: 6PU1E16C9W)
  • DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
  • PEG-75 LANOLIN (UNII: 09179OX7TB)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • WATER (UNII: 059QF0KO0R)

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
Marketing Category: UNAPPROVED DRUG OTHER - 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: 02-15-2019 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.

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%

Purpose

Lubricant laxative

Astringent

Uses

  • For relief of occasional constipationfor relief of fecal impactionfor removal of residue after barium administrationThis product usually produces a bowel movement in 2 to 15 minutes.

  • Helps relieve the local itching and discomfort associated with hemorrhoidstemporary relief of irritation and burningaids in protecting irritated anorectal areas

Warnings

For rectal use only

For external use only

Do Not Use

When abdominal pain, nausea, or vomiting are present unless directed by a doctor

Ask A Doctor Before Using This Product If You

  • Have a sudden change in bowel habits lasting more than 2 weeksalready used a laxative for more than 1 week

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.

If Pregnant Or Breast-Feeding,

Ask a health professional before use.

Ask a health professional before use.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

If swallowed, get medical help or contact a Posion Control Center (1-800-222-1222) right away.

Directions

Single Daily Dosage (per 24 hours)adults and children 12 years and over 1 bottle per daychildren 2 to under 12 yearsone-half bottlechildren under 2DO NOT USE

  • Adults: unfold wipe and cleanse the area by gently wiping, patting or blotting. if necessary, repeat until all matter is removed from the area.use up to 6 times daily or after each bowel movement and before applying topical hemorrhoidal treatments and then discardchildren under 12 years of age: consult a doctor

Other Information

  • Sodium-freefor complete Professional Use, Warnings and Precautions, consult the Reference Safety Information on our website

  • Store at 20º-25ºC (68º-77ºF)for best results, flush only one or two wipes at a time

Questions?

1-866-255-6960 or www.fleetlabs.comTamper Evident bottle sealed for safety. If bottle wrapper with Fleet® emblem is torn, damaged or missing, do not use.Hemorrhoidal Relief Wipes Drug Facts

Active Ingredient

Witch hazel 50.%

When Using This Product

  • Do not exceed the recommended daily dosage unless directed by a doctordo not put this product into the rectum by using fingers or any mechanical device or applicator

Stop Use And Ask A Doctor If

  • Bleeding occurscondition worsens or does not improve within 7 days

Inactive Ingredients

Aloe vera leaf, anhydrous citric acid, bronopol, disodium cocoamphodiacetate, glycerin, iodopropynyl butylcarbamate, PEG-75 lanolin, propylene glycol, sodium citrate, water

* Please review the disclaimer below.