FLEET- mineral oil and witch hazel 
C.B. Fleet Company, Inc.

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.

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Fleet Gentle Relief Kit

Mineral Oil enema

Drug Facts

Active ingredient (in each 118 mL delivered dose)

Mineral Oil 100%

Purpose

Lubricant laxative

Uses

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

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

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

Other information

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

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)

Revised: 6/2020
Document Id: 97018b06-e1e1-42b1-8f5d-beb958c74b17
Set id: 7b5dbbed-8ada-49a1-8773-1559048bfa1c
Version: 3
Effective Time: 20200629
 
C.B. Fleet Company, Inc.