Active Ingredient(S)
Petrolatum 60%. Purpose: Skin protectant
Dr527
FDA Label NDC 68726-527
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Physicians Care Alliance, Llc Dba Pca Skin for the product Dr527 (NDC 68726-527). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient(s), purpose, use, warnings, do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Skin Ointment, Skin protectant
Use
Helps relieve, prevent and temporarily protect chafed, chapped or cracked skin. Use as a lubricant to prevent further irritation.
Warnings
For external use only.
Do Not Use
on deep or puncture wounds
on animal bites
on serious burns
on damaged and broken skin
Otc - When Using
When using this product do not get into eyes
Stop use and ask a doctor if:
conditions worsens
symptoms last more than 7 days or clear up and occur again within a few days
Keep out of reach of children.
Otc - Stop Use
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
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Directions
- Apply as needed or as directed by physician
- For best results, apply liberally to moist skin
Other Information
- Do not use if package is broken or open
- Protect this product from excessive heat and direct sun
- noncomedogenic
- fragrance-free
- hypoallergenic
Inactive Ingredients
Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Seed Oil, Helianthus Annuus (Sunflower) Extract, Helianthus Annuus (Sunflower) Seed Wax, Oryza Sativa (Rice) Bran Extract, Panthenol, Phenoxyethanol, Rosmarinus Officinalis (Rosemary) Leaf Extract, Silybum Marianum Fruit Extract, Stearyl Glycrrhetinate, Tocopherol, Tocopheryl Acetate.
Package Label - Principal Display Panel
207 mL NDC: 68726-527-01
* Please review the disclaimer below.
