FLEET- mineral oil enema 
C.B. Fleet Company, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.


Drug Facts

Active Ingredient

(in each 118-mL delivered dose)

Mineral Oil 100% ......Lubricant Laxative



For rectal use only.

If pregnant or breast-feeding ask a health professional before use.


Single daily dose

adults and children 12 years and over
1 bottle

children 2 to under 12 years
one-half bottle

children under 2 years

Other Information

Other Information


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

Ask a doctor before using any laxative if you have

Stop use and ask a doctor if you have

These symptoms may indicate a serious condition.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

image description

mineral oil enema
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0132-0301
Route of Administration RECTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Mineral Oil (UNII: T5L8T28FGP) (Mineral Oil - UNII:T5L8T28FGP) Mineral Oil 118 mL  in 118 mL
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0132-0301-40 133 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part334 05/01/2002
Labeler - C.B. Fleet Company, Inc. (003119054)
Name Address ID/FEI Business Operations
C.B. Fleet Company, Inc. 003119054 manufacture(0132-0301)

Revised: 2/2013
Document Id: cc07b787-9d74-43c7-9efd-7877dd0efe41
Set id: 2528cb5e-437e-41f0-9c34-e9ce57404d8b
Version: 8
Effective Time: 20130213
C.B. Fleet Company, Inc.