PCA SKIN SKIN PROCEDURE- petrolatum ointment

PCA Skin Skin Procedure by

Drug Labeling and Warnings

PCA Skin Skin Procedure by is a Otc medication manufactured, distributed, or labeled by CP Skin Health Group, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Petrolatum 60%

Purpose

Skin protectant (ointment)

Uses

temporarily protects minor: º cuts º scrapes º 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 

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

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
• noncomedogenic 
• fragrance-free
• hypoallergenic

Inactive ingredients

Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Carthamus Tincotirius (Safflower) Seed Oil, Helianthus Annuus (Sunflower) Extract, Helianthus Annuus (Sunflower) Seed Wax, Oryza Sativa (Rice) Bran Extract, Panthenol, Phenoxyethanol, Rosamarinus Officinalis (Rosemary) Leaf Extract, Silybum Marianum Fruit Extract, Stearyl Glycyrrhetinate, Tocopherol, Tocopheryl Acetate.

Questions?

Please call 877.722.7546

Package Labeling:

INGREDIENTS AND APPEARANCE

PCA SKIN SKIN PROCEDURE 
petrolatum ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68726-680
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	600 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SHEA BUTTER (UNII: K49155WL9Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SAFFLOWER OIL (UNII: 65UEH262IS)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
RICE BRAN (UNII: R60QEP13IC)
PANTHENOL (UNII: WV9CM0O67Z)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ROSEMARY (UNII: IJ67X351P9)
MILK THISTLE (UNII: U946SH95EE)
STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P)
TOCOPHEROL (UNII: R0ZB2556P8)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68726-680-01	62.1 mL in 1 TUBE; Type 0: Not a Combination Product	09/10/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M016	09/10/2019

Labeler - CP Skin Health Group, Inc. (611921669)