PERSONAL SKINCARE BARRIER CREAM- zinc oxide barrier cream cream

Personal Skincare Barrier Cream by

Drug Labeling and Warnings

Personal Skincare Barrier Cream by is a Otc medication manufactured, distributed, or labeled by Cardinal Health, Swiss-American CDMO, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Warnings

For external use only. Avoid contact with the eyes.  Stop use and contact physician if condition worsens, symptoms last more than 7 days or clear up and occur again within a few days. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Do not use on deep or puncture wounds, animal bites or serious burns.

Active Ingredients

Zinc Oxide 6%   Skin Protectant

Keep out of reach of children

Keep out of reach of children

Uses

For the temporary protection of minor burns, cuts, scrapes.  Helps treat and prevent diaper rash.  Protects chafed skin associated with diaper rash.  Protects from wetness.  Dires the oozing and weeping of poison ivy, oak and sumac.

INDICATIONS & USAGE

For the temporary protection of minor burns, cuts, scrapes. Helps treat and prevent diaper rash. Protects chafed skin associated with diaper rash. Protects from wetness. Dires the oozing and weeping of poison ivy, oak and sumac.

Directions

Gently cleanse and remove any urine or fecal matter from treatment area.  pat dry.  Apply a generous amount of product to the affected area.  Repeat after every incontinent episode or as needed.  For peri-G tubes: cleanse as above.  Apply thin layer.  Secure with drain sponge or product as directed.

Other Information

Store between 15-30C (59-86F)

Questions

For product concerns or questions please call 1-877-227-3462 or visit cardinalhealth.com/products

Inactive Ingredients

bees wax, cetyl dimethicone, cetyl PEG/PPG-10/1 dimethicone, dimethicone, disodium EDTA, hydrogenated castor oil, isopropyl palmitate, methylparaben, petrolatum, propylene glycol, propylparaben, purified water, sodium chloride

Labeling

INGREDIENTS AND APPEARANCE

PERSONAL SKINCARE BARRIER CREAM 
zinc oxide barrier cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63517-082
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	60 g  in 1000 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PETROLATUM (UNII: 4T6H12BN9U)
DIMETHICONE 1000 (UNII: MCU2324216)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
CETYL DIMETHICONE 45 (UNII: IK315POC44)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63517-082-02	58 g in 1 TUBE; Type 0: Not a Combination Product	01/21/2020
2	NDC: 63517-082-04	113 g in 1 TUBE; Type 0: Not a Combination Product	01/21/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	01/21/2020

Labeler - Cardinal Health (961027315)

Registrant - Swiss-American CDMO, LLC (080170933)

Establishment
Name	Address	ID/FEI	Business Operations
Swiss-American CDMO, LLC		080170933	manufacture(63517-082)