Label: MINERAL OIL oil
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated August 28, 2017
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- 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
- INDICATIONS & USAGE
Ask a doctor before using laxative if you:
- Have nausea, vomiting, or abdominal pain
- Have suddent change in bowel habits lasting more than two weeks
- Have already used a laxative for more than 1 week
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.
- Stop using this product and consult a doctor if you:
- PREGNANCY OR BREAST FEEDING
- INACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
mineral oil oil
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54162-175 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 g Inactive Ingredients Ingredient Name Strength VITAMIN D (UNII: 9VU1KI44GP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54162-175-05 113 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product 07/31/2015 2 NDC:54162-175-12 113 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product 07/31/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 07/31/2015 Labeler - GERITREX LLC (112796248) Registrant - GERITREX LLC (112796248) Establishment Name Address ID/FEI Business Operations GERITREX LLC 112796248 repack(54162-175) Establishment Name Address ID/FEI Business Operations Calumet Penreco LLC 114222776 manufacture(54162-175)