MINERAL OIL- mineral oil oil 
GERITREX LLC

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.

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Mineral Oil Enema

Active Ingredient:                          Purpose:
Mineral Oil USP 100%......................Lubricant Laxative

Uses:

For relief of fecal impaction or occasional constipation, without straining or irritating the mucosa of the bowel, by lubricating and softening the stool. Generally produces bowel movement in 2 to 15 minutes.

Professional Use:
For cleansing the bowel and removal of residue after barium enema administration

Dosage wanring: Using more than one enema in 24 hours can be harmful

​Caution: For rectal use only

Ask a doctor before using laxative if you:


​Ask a doctor of pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

​When using this product, do not use more than directed.

Serious side effects may occur from excess dosage.

​Stop using this product and consult a doctor if you:

These symptoms may indicated a serious condition.

​If pregnant or breastfeeding​Ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN
In the case of accidental ingestion contact a Poison Control Center right away

Remove orange protective shield before inserting by holding bottle upright, grasping bottle cap with fingers. Grasp protective shield with other hand and pull gently to remove, then insert lubricated tip into rectum and squeeze gently.

Store at room temperature 59°-86°F (15°-30°C)

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MINERAL OIL 
mineral oil oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-175
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL100 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
VITAMIN D (UNII: 9VU1KI44GP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54162-175-05113 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product07/31/2015
2NDC:54162-175-12113 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product07/31/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33407/31/2015
Labeler - GERITREX LLC (112796248)
Registrant - GERITREX LLC (112796248)
Establishment
NameAddressID/FEIBusiness Operations
GERITREX LLC112796248repack(54162-175)
Establishment
NameAddressID/FEIBusiness Operations
Calumet Penreco LLC114222776manufacture(54162-175)

Revised: 8/2017
Document Id: e37fe39a-b729-4e3c-9f79-e1f50f6c74d4
Set id: 2d035d8f-9914-4378-b976-aa0d851caa3a
Version: 3
Effective Time: 20170828
 
GERITREX LLC