Label: FLEET- mineral oil and witch hazel kit

  • NDC Code(s): 0132-0705-00
  • Packager: C.B. Fleet Company, Inc.
  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated June 29, 2020

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • SPL UNCLASSIFIED SECTION

    Mineral Oil enema

    Drug Facts

  • Active ingredient (in each 118 mL delivered dose)

    Mineral Oil 100%

  • Purpose

    Lubricant laxative

  • Uses

    • for relief of occasional constipation
    • for relief of fecal impaction
    • for removal of residue after barium administration

    This product usually produces a bowel movement in 2 to 15 minutes.

  • Warnings

    For rectal 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 weeks
    • already used a laxative for more than 1 week

    Stop use and ask a doctor if you have

    • rectal bleeding
    • no bowel movement within 15 minutes of using this product

    These symptoms may indicate a serious condition.

    If pregnant or breast-feeding,

    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.

  • Directions

    Single Daily Dosage (per 24 hours)

    adults and children 12 years and over 1 bottle per day
    children 2 to under 12 yearsone-half bottle
    children under 2DO NOT USE
  • Other information

    • sodium-free
    • for complete Professional Use, Warnings and Precautions, consult the Reference Safety Information on our website
  • Questions?

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

    Tamper 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.%

  • Purpose

    Astringent

  • Uses

    • helps relieve the local itching and discomfort associated with hemorrhoids
    • temporary relief of irritation and burning
    • aids in protecting irritated anorectal areas
  • Warnings

    For external use only

    When using this product

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

    Stop use and ask a doctor if

    • bleeding occurs
    • condition worsens or does not improve within 7 days

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

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

  • Directions

    • 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 discard
    • children under 12 years of age: consult a doctor
  • Other information

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

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

  • PRINCIPAL DISPLAY PANEL

    Fleet®

    LUBRICANT LAXATIVE HEMORRHOIDAL WIPES
    Gentle Relief Kit

    2 MINERAL OIL enemas - 2 Bottles 4.5 fl oz (133 mL) each 

    2 hemorrhoidal wipes WITCH HAZEL WITH ALOE - 2 Individually Wrapped Flushable Wipes

    Fleet® 

LUBRICANT LAXATIVE HEMORRHOIDAL WIPES
Gentle Relief Kit

2 MINERAL OIL enemas - 2 Bottles 4.5 fl oz (133 mL) each 
2 hemorrhoidal wipes WITCH HAZEL WITH ALOE - 2 Individually Wrapped Flushable Wipes

  • INGREDIENTS AND APPEARANCE
    FLEET 
    mineral oil and witch hazel kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0132-0705
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0132-0705-001 in 1 CARTON; Type 0: Not a Combination Product02/15/2019
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, WITH APPLICATOR 133 mL
    Part 21 CARTON
    Part 1 of 2
    FLEET 
    mineral oil enema
    Product Information
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL100 g  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    12 in 1 CARTON
    1133 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart33405/01/2002
    Part 2 of 2
    FLEET 
    witch hazel cloth
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL5 g
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    12 in 1 CARTON; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34602/15/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER02/15/2019
    Labeler - C.B. Fleet Company, Inc. (003119054)