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

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 years	one-half bottle
children under 2	DO 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 Flushab

FLEET
mineral oil and witch hazel kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0132-0705

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0132-0705-00	1 in 1 CARTON; Type 0: Not a Combination Product	02/15/2019	01/01/2022

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 CARTON	2

Part 1 of 1

FLEET
witch hazel cloth

Product Information
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34)	WITCH HAZEL	5 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		2 in 1 CARTON; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part346	02/15/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		02/15/2019	01/01/2022

Labeler - C.B. Fleet Company, Inc. (003119054)

Name	Address	ID/FEI	Business Operations
Establishment
Nice-Pak Products, Inc.		067900167	manufacture(0132-0705)

Revised: 11/2022

Document Id: ecaa652a-d6c5-321f-e053-2995a90aff6a

Set id: 7b5dbbed-8ada-49a1-8773-1559048bfa1c

Version: 4

Effective Time: 20221104

C.B. Fleet Company, Inc.