Mineral Oil — v11

Mineral Oil

4 Views

Version

v11

Effective date

September 26, 2025

Original packager

Yes

Sections captured

17

Identifiers

Document ID
3fb6ec78-c59d-c9a5-e063-6394a90a571a
Set ID
e9b1fd61-c229-4529-82c2-d6ac5b076082
Application numbers
M007
Product NDCs
36800-931
Package NDCs
36800-931-43
Original packager NDCs

Names & Manufacturers

Brand names
Mineral Oil
Generic names
MINERAL OIL
Manufacturer names
TopCo Associates
Product types
HUMAN OTC DRUG

Substances & Pharmacology

Substance names
MINERAL OIL
Routes
ORAL, TOPICAL
Pharmacologic class (PE)
Pharmacologic class (EPC)
Pharmacologic class (CS)
Mechanism of action

Other identifiers

NUI
RxCUI
705909
UNII
T5L8T28FGP
UPC

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active ingredient Mineral oil 99.9%
Ask Doctor (1)

Sequence 1

Ask a doctor before use if you have abdominal pain, nausea, or vomiting noticed a sudden change in bowel habits that persists over a period of 2 weeks
Ask Doctor Or Pharmacist (1)

Sequence 1

Ask a doctor or pharmacist before use if you are presently taking a stool softener laxative taking any other drug. Take this product 2 or more hours before or after other drugs. Laxatives may affect how other drugs work.
Do Not Use (1)

Sequence 1

Do not use if you have difficulty swallowing in children under 6 years of age if you are pregnant for a period longer than week if you are bedridden or aged
Dosage And Administration (1)

Sequence 1

Directions do not take with meals take only at bedtime may be taken as a single daily dose or in divided doses adults and children 12 years of age and over - 1 to 3 Tablespoons (15 - 45 mL) maximum 3 Tablespoons (45 mL) in 24 hours children 6 to under 12 years of age - 1 to 3 teaspoons (5 - 15 mL) maximum 3 teaspoons (15 mL) in 24 hours children under 6 years of age - do not use, consult a doctor
Inactive Ingredient (1)

Sequence 1

Inactive ingredients mixed tocopherols (added as a stabilizer)
Indications And Usage (1)

Sequence 1

Use for relief of occasional constipation (irregularity). Generally produces bowel movement in 6 to 8 hours.
Keep Out Of Reach Of Children (1)

Sequence 1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Package Label Principal Display Panel (1)

Sequence 1

principal display panel NDC 36800-931-43 TopCare ® health Mineral Oil U.S.P. LUBRICANT LAXATIVE For Relief of Occasional Constipation Odorless Tasteless Colorless DISTRIBUTED BY TOPCO ASSOCIATES LLC ELK GROVE VILLAGE, IL 60007 ©TOPCO VIJA0521 QUESTIONS? 1-888-423-0139 topcare@topco.com www.topcareband.com PRODUCT OF USA WITH US AND FOREIGN COMPONENTS SEALED WITH PRINTED FOIL UNDER CAP FOR YOUR PROTECTION Scan here for more information or call 1-888-423-0139 16 FL OZ (1 PT) 473 mL image description image description
Pregnancy Or Breast Feeding (1)

Sequence 1

If breast-feeding, ask a health professional before use
Purpose (1)

Sequence 1

Purpose Lubricant laxative
Questions (1)

Sequence 1

Questions? Call 1-888-423-0139
Spl Product Data Elements (1)

Sequence 1

Mineral Oil Mineral Oil TOCOPHEROL MINERAL OIL MINERAL OIL
Spl Unclassified Section (2)

Sequence 1

Claim QUALITY GUARANTEED

Sequence 2

Other information keep tightly closed. Protect from sunlight.
Stop Use (1)

Sequence 1

Stop use and ask a doctor if you have rectal bleeding or failure to have a bowel movement after use. These could be signs of a serious condition.
Warnings (1)

Sequence 1

Warnings for this product
When Using (1)

Sequence 1

When using this product do not take with meals. Take only at bedtime.

OpenFDA raw payload

{'application_number': ['M007'],
 'brand_name': ['Mineral Oil'],
 'generic_name': ['MINERAL OIL'],
 'is_original_packager': [True],
 'manufacturer_name': ['TopCo Associates'],
 'package_ndc': ['36800-931-43'],
 'product_ndc': ['36800-931'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['ORAL', 'TOPICAL'],
 'rxcui': ['705909'],
 'spl_id': ['3fb6ec78-c59d-c9a5-e063-6394a90a571a'],
 'spl_set_id': ['e9b1fd61-c229-4529-82c2-d6ac5b076082'],
 'substance_name': ['MINERAL OIL'],
 'unii': ['T5L8T28FGP']}