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']}