Mineral Oil

Manufacturer
Blossom Pharmaceuticals
Effective date
2014-01-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:38:18

Label at a glance#

ProductMineral Oil
Active ingredientMINERAL OIL
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient                            Purpose

Mineral Oil, 100%                    Lubricant Laxative            

Purpose

OTC - PURPOSE SECTION

  • Gentle relief of occasional constipation

Warnings:

WARNINGS SECTION

For rectal use only

As a doctor before use if you have:

OTC - ASK DOCTOR SECTION

  • abdominal pain, nausea or vomiting
  • notice a sudden change in bowel habits that persists over a period of 2 weeks

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

Indications & Usage

INDICATIONS & USAGE SECTION

  • If you have rectal bleeding or failure to have a bowel movement after use of a laxative because this amy indicate a serious condition
  • you need to use a laxative for more than one week

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Other information:

SPL UNCLASSIFIED SECTION

  • Store at room temperature 20 Deg C - 25 Deg C (68 Deg F - 77 Deg F)
  • This product produces bowel movement in 2 to 15 minutes

Dosage & Administration

DOSAGE & ADMINISTRATION SECTION

Single daily dose

Adults and children 12 years and older - 1 bottle

Children 2 to under 12 years - 1/2 bottle

Children under 2 years - Do not use. Consult a physician.


How to use this enema:

REMOVE GREEN PROTECTIVE SHIELD BEFORE INSERTING.

Hold bottle upright, grasping bottle cap with fingers. Grasp protective shield with the other hand and pull gently to remove.

See image on box

Positioning

Left-side position: Lie on left side with knee bent and arms at rest.

See image on box

Knee-chest position: Kneel, then lower head and chest forward until the left side of face is resting on surface. Position arms comfortably.

See image on box

Administering Enema

  • With steady pressure, gently insert enema with tip pointing toward navel.
  • Squeeze bottle until recommended dose is expelled (it is not necessary to

    empty unit completely. Bottle contains more liquid than needed for effective

    use. A small amount of liquid will remain in bottle after squeezing).

  • Remove tip from rectum.

  • Stop using if tip is hard to insert. Forcing the tip into the rectum can

    cause injury (especially if you have hemorrhoids). If enema tip causes

    rectal bleeding or pain, get immediatemedical care.

  • Maintain position until urge to evacuate is strong (usually 1 to 5 minutes).

  • If no urge is felt after 5 minutes of using, try to empty bowel. Call a doctor

    promptly if no liquid comes out of the rectum after 30 minutes because

    dehydration could occur.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Mineral oil enema.jpg

Mineral oil enemaMineral oil enema

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
205121mineral oil 100 % EnemaPSN1
205121mineral oil 1000 MG/ML EnemaSCD1
205121mineral oil 100 % EnemaSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61767-001-012020-01-31C16284748780-19d75b9d0-1e13-f424-e053-dadaa90a57ceEnema, Mineral Oil

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61767-001-01Mineral Oil1 in 1 BOXENEMA11
61767-001-01Mineral Oil118 mL in 1 BOTTLEENEMA1181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61767-001MINERAL OIL ENEMA [BLOSSOM PHARMACEUTICALS]1Legacy NDC, 2 package rows20140201_e0d31f14-5e11-4370-b0c6-adb639db164c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MINERAL OILACTIVE INGREDIENTT5L8T28FGP1
MINERAL OILACTIVE MOIETYT5L8T28FGP1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 1 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61767-00161767-001-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
MINERAL OILT5L8T28FGPACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
8f1f9218-cdf8-4217-af36-2269f532b7fee0d31f14-5e11-4370-b0c6-adb639db164c2014-01-29WarningsExact identifier
spl id: 8f1f9218-cdf8-4217-af36-2269f532b7fe
spl set id: e0d31f14-5e11-4370-b0c6-adb639db164c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.