SHEFFIELD ZINC OXIDE- zinc oxide ointment

Sheffield Zinc Oxide by

Drug Labeling and Warnings

Sheffield Zinc Oxide by is a Otc medication manufactured, distributed, or labeled by Sheffield Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Zinc oxide 20%

Purpose

Skin Protectant

Uses

• helps treat and prevent diaper rash. Protects chafed skin due to diaper rash and helps seal out wetness.
• dries the oozing and weeping of poison ivy, poison oak and poison sumac.

Warnings

For external use only

When using this product, avoid contact with the eyes

Stop use and ask a doctor if condition worsens or does not improve within 7 days

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Directions

• apply liberally as often as necessary

For diaper rash:

• change wet or soiled diapers promptly
• cleanse the diaper area and allow to dry
• apply ointment liberally, as often as necessary, with each diaper change and especially at bedtime or anytime when exposure to wet diapers may be prolonged

Inactive ingredients

mineral oil, petrolatum

Questions or comments?

Call 1-800-222-1087

Store at room temperature 20° - 25°C (68° - 77°F).

PRINCIPAL DISPLAY PANEL

Sheffield Pharmaceuticals -Tube label 

SKIN PROTECTANT

Zinc Oxide
Ointment USP
provides soothing relief from poison ivy,
oak and sumac
Treats and prevents diaper rash

NET WT 1 OZ (28g)

PRINCIPAL DISPLAY PANEL

Sheffield Pharmaceuticals Zinc Oxide Ointment USP- Carton label 

Skin protectant 

Help Soothe & Protect Chafed Skin

NET WT 1 oz (28g)

INGREDIENTS AND APPEARANCE

SHEFFIELD ZINC OXIDE 
zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11527-065
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	200 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11527-065-34	1 in 1 CARTON	01/11/2005
1		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	01/11/2005

Labeler - Sheffield Pharmaceuticals LLC (151177797)