FLEET- mineral oil and witch hazel kit

FLEET by

Drug Labeling and Warnings

FLEET by is a Otc medication manufactured, distributed, or labeled by C.B. Fleet Company, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 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®

Gentle Relief Kit

lubricant laxative + hemorrhoidal relief wipes

2 Mineral Oil enemas - 2 Bottles 4.5 fl oz (133 mL) each 

2 Hemorrhoidal Relief Wipes (Witch hazel) - 2 Individually Wrapped Flushable Wipes

INGREDIENTS AND APPEARANCE

FLEET 
mineral oil and witch hazel kit

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

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

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE, WITH APPLICATOR	133 mL
Part 2	1 CARTON	2

Part 1 of 2

FLEET 
mineral oil enema

Product Information
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	100 g  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		2 in 1 CARTON
1		133 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part334	05/01/2002

Part 2 of 2

FLEET 
witch hazel cloth

Product Information
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1		2 in 1 CARTON; Type 0: Not a Combination Product

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		02/15/2019

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