Version
v2
Effective date
September 29, 2025
Original packager
Yes
Sections captured
15
Identifiers
- Document ID
- 3ff75d89-5710-f9c4-e063-6394a90a744d
- Set ID
- 3492f044-250e-45f7-8638-e3c55713e0f5
- Application numbers
- M016
- Product NDCs
- 50804-050
- Package NDCs
- 50804-050-04, 50804-050-13
- Original packager NDCs
- —
Names & Manufacturers
- Brand names
- GoodSense Petroleum Jelly
- Generic names
- WHITE PETROLATUM
- Manufacturer names
- GOOD SENSE
- Product types
- HUMAN OTC DRUG
Substances & Pharmacology
- Substance names
- PETROLATUM
- Routes
- TOPICAL
- Pharmacologic class (PE)
- —
- Pharmacologic class (EPC)
- —
- Pharmacologic class (CS)
- —
- Mechanism of action
- —
Other identifiers
- NUI
- —
- RxCUI
- —
- UNII
- 4T6H12BN9U
- UPC
- —
Structured Label Sections
Active Ingredient (1)
Sequence 1
White Petroleum USP 100% Active ingredients Purpose White Petrolatum 100% Skin Protectant
Active Ingredient Table (1)
Sequence 1
Active ingredients | Purpose |
---|
White Petrolatum 100% | Skin Protectant |
Do Not Use (1)
Sequence 1
Do not use on deep or puncture wounds . animal bites serious burns.
Dosage And Administration (1)
Sequence 1
Directions Apply as needed
Inactive Ingredient (1)
Sequence 1
Inactive ingredient Water
Indications And Usage (1)
Sequence 1
Uses temporarily protects: minor cuts, scrapes, burns chapped or cracked skin and lips from the drying effects of wind and cold weather
Keep Out Of Reach Of Children (1)
Sequence 1
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Package Label Principal Display Panel (1)
Sequence 1
GoodSense Petroleum Jelly label label 4oz
Purpose (1)
Sequence 1
Active ingredients Purpose White Petrolatum 100% Skin Protectant
Purpose Table (1)
Sequence 1
Active ingredients | Purpose |
---|
White Petrolatum 100% | Skin Protectant |
Spl Product Data Elements (1)
Sequence 1
GoodSense Petroleum Jelly White Petrolatum WATER PETROLATUM PETROLATUM
Spl Unclassified Section (1)
Stop Use (1)
Sequence 1
Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days
Warnings (1)
Sequence 1
Warnings For external use only When using this product do not get into eyes Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days Do not use on deep or puncture wounds . animal bites serious burns. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
When Using (1)
Sequence 1
When using this product do not get into eyes
OpenFDA raw payload
{'application_number': ['M016'],
'brand_name': ['GoodSense Petroleum Jelly'],
'generic_name': ['WHITE PETROLATUM'],
'is_original_packager': [True],
'manufacturer_name': ['GOOD SENSE'],
'package_ndc': ['50804-050-13', '50804-050-04'],
'product_ndc': ['50804-050'],
'product_type': ['HUMAN OTC DRUG'],
'route': ['TOPICAL'],
'spl_id': ['3ff75d89-5710-f9c4-e063-6394a90a744d'],
'spl_set_id': ['3492f044-250e-45f7-8638-e3c55713e0f5'],
'substance_name': ['PETROLATUM'],
'unii': ['4T6H12BN9U']}