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

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Drug Label Information

Updated June 29, 2020

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  • 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 2 
    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)
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