PROSKI SHIELD- dimethicone, zinc oxide cream

PROSKI SHIELD by

Drug Labeling and Warnings

PROSKI SHIELD by is a Otc medication manufactured, distributed, or labeled by PHARMAMED USA INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Zinc Oxide 2%

Dimethicone 1.8%

Purpose

• Diaper rash
• Skin Protectant

Uses

• Use as a general skin protectant
• Helps treat chafed skin associated with diaper & nappy rash

Warnings

For External Use Only.

When using this product:

• Avoid contact with eyes
• Do not use over large areas of the body
• So not use if you are alergic to any of the ingredients

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

Keep out of reach of children:

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away

Directions

• For diaper rash: Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry. Apply cream liberally as often as necessary with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.
• For other uses: Apply as needed.

Other Information

• Store at room temperature between 15º - 30ºC (59º - 86ºF)
• Avoid excessive heat
• Tamper evident. Do not use if the seal is damaged.

Inactive Ingredients

Aloe Vera Leaf, Alpha-Tocopherol (Vitamin E), CETETH-20, Cetostearyl Alcohol, Cetyl Alcohol, Glycerin, Lanolin, Lavender Oil, Methylparaben, Mineral Oil, Propylparaben, Yellow 5, Trolamine, Vitamin A Acetate, Vitamin D3, Water, White Petrolatum

Questions and Comments?

(754)-200-8994 (Mon-Fri 8 AM to 4 PM EST)

Package/Label Principal Display Panel

NDC: 84289-408-02

DIMETHICONE SKIN PROTECTANT BARRIER CREAM WITH

■ Vitamin A ■ Vitamin D ■ Vitamin E ■ Zinc Oxide ■ Aloe Vera

Enhanced Formula

Net Wt 4 oz. (113 g)

GOA/DRUGS/571

INGREDIENTS AND APPEARANCE

PROSKI SHIELD 
dimethicone, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84289-408
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	2 g  in 100 g
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	1.8 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
TROLAMINE (UNII: 9O3K93S3TK)
WHITE PETROLATUM (UNII: B6E5W8RQJ4)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
VITAMIN A ACETATE (UNII: 3LE3D9D6OY)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
CETETH-20 (UNII: I835H2IHHX)
LAVENDER OIL (UNII: ZBP1YXW0H8)
YELLOW 5 (UNII: I753WB2F1M)
METHYLPARABEN (UNII: A2I8C7HI9T)
CETYL ALCOHOL (UNII: 936JST6JCN)
LANOLIN (UNII: 7EV65EAW6H)
MINERAL OIL (UNII: T5L8T28FGP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84289-408-02	113 g in 1 TUBE; Type 0: Not a Combination Product	04/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	04/01/2025

Labeler - PHARMAMED USA INC (065607328)