DR527- skin procedure ointment ointment

DR527 by

Drug Labeling and Warnings

DR527 by is a Otc medication manufactured, distributed, or labeled by Physicians Care Alliance, LLC dba PCA Skin. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Petrolatum (60%)

Purpose

Skin protectant (ointment)

Uses

Helps relieve, prevent and temporarily protect chafed, chapped or cracked skin. Use as a lubricant to prevent further irritation.

Warnings

For external use only

When using this product

do not get into eyes

Stop use and ask a doctor it

• 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

Do not use

on damaged and broken skin

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
• noncomedogic
• fragrance-free
• hypoallergenic

Questions?

Please call 877.722.7546

Directions

• Apply as needed or as directed by physician
• for best results, apply liberally to moist skin

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 Glycyrrhetinate, Tocopherol, Tocopheryl Acetate.

Uses

• temporarily protects minor: - cuts - scrapes - burns
• helps prevent and temporarily protects and helps relieve chafed, chapped or cracked skin
• helps prevent and protect skin from the drying effects of wind and cold weather

Label

INGREDIENTS AND APPEARANCE

DR527 
skin procedure ointment ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68726-527
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	124 g  in 207 mL

Inactive Ingredients
Ingredient Name	Strength
SAFFLOWER OIL (UNII: 65UEH262IS)	67 mL  in 207 mL
PANTHENOL (UNII: WV9CM0O67Z)	4 mL  in 207 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68726-527-01	207 mL in 1 TUBE; Type 0: Not a Combination Product	07/20/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	07/20/2020

Labeler - Physicians Care Alliance, LLC dba PCA Skin (969945133)