Label: ENEMA MINERAL OIL- mineral oil enema
- NDC Code(s): 67234-019-01
- Packager: Natureplex LLC
- 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 January 16, 2020
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- SPL UNCLASSIFIED SECTION
- Active ingredient (in each 120 ml delivered dose)
For rectal use only.
To be taken only at bedtime. Do not use at any other time or administer to infants, except upon the advice of a physician.
Do not use
- on children under 13 years of age
- on pregnant women
- on persons with difficulty swallowing
- on bedridden patients
- if you are presently taking a stool softener laxative
- or take with meals
Ask a doctor before use if you
- have already used a laxative for more than 3 days
- have abdominal pain, nausea, or vomiting
- have a sudden change in bowel habits that persist over a period of 2 weeks
Stop use and ask a doctor if
- you have rectal bleeding
- you have no bowel movement within 30 minutes of enema use
As with any drug, if you are nursing a baby, seek the advice of a health professional before using this product.
- Directions (or as directed by a doctor)
- Other information
- Inactive ingredient
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton
INGREDIENTS AND APPEARANCE
ENEMA MINERAL OIL
mineral oil enema
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67234-019 Route of Administration RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Mineral Oil (UNII: T5L8T28FGP) (Mineral Oil - UNII:T5L8T28FGP) Mineral Oil 118 g in 118 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67234-019-01 1 in 1 CARTON 01/05/2013 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 01/05/2013 Labeler - Natureplex LLC (062808196) Establishment Name Address ID/FEI Business Operations Natureplex LLC 062808196 MANUFACTURE(67234-019)