Label: LEADER READY TO USE MINERAL OIL LAXATIVE- mineral oil enema
- NDC Code(s): 70000-0109-1
- Packager: Cardinal Health
- 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.
Drug Label Information
Updated June 21, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each 118 mL delivered dose)
- Purpose
- Uses
-
Warnings
For rectal use only
Ask a doctor before use
- if you have abdominal pain, nausea, or vomiting
- if you have a sudden change in bowel habits that persists over a period of 2 weeks
- if you have already used a laxative for more than 1 week
- if constipation continues after one week of use, contact your doctor
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
-
PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton
LEADER™
NDC 70000-0109-1
Ready-To-Use
Enema
Mineral Oil
Lubricant LaxativeSodium Free
For Relief Of:
Occasional
ConstipationComfortable,
Lubricated TipWorks in
MinutesNot Made
With Natural
Rubber
LatexCOMPARE TO
FLEET® MINERAL
OIL ENEMA
active ingredient*1 BOTTLE
100% Money
Back Guarantee4 .5 FL OZ (133 mL)
-
INGREDIENTS AND APPEARANCE
LEADER READY TO USE MINERAL OIL LAXATIVE
mineral oil enemaProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0109 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:70000-0109-1 1 in 1 CARTON 02/19/2013 1 133 mL in 1 BOTTLE; 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 02/19/2013 Labeler - Cardinal Health (063997360) Establishment Name Address ID/FEI Business Operations Natureplex LLC 062808196 MANUFACTURE(70000-0109)