DR. SHEFFIELD DIAPER RASH- zinc oxide ointment

Dr. Sheffield Diaper Rash by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Zinc Oxide 40%

Purpose

Skin protectant

Uses

• helps treat and prevent diaper rash
• protects chafed skin due to diaper rash and helps seal out wetness

Warnings

For external use only

When using this product

• avoid contact with 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

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

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

Other information

store at room temperature 15° - 30°C (59° - 86°F)

Inactive ingredients

BHA, Cod liver oil, Fragrance, Lanolin, Petrolatum, Talc, Water

PRINCIPAL DISPLAY PANEL

Principal Display Panel - Carton Label

NDC: 11527-058-41

Dr. Sheffield's

Made in the USA

Diaper Rash
Ointment

40% Zinc Oxide Skin Protectant

Promotes healing

Relieves chafing

Paraben free

Helps Treat and
Prevent Diaper Rash

NET WT. 2 oz. (56g)

PRINCIPAL DISPLAY PANEL

Principal Display Panel - Tube Label

SHEFFIELD PHARMACEUTICALS www.sheffield-pharmaceuticals.com New London, CT 06320 USA

Questions? 1-800-222-1087 Made in the USA

NDC: 11527-058-41

Dr. Sheffield's

Made in the USA

Diaper Rash
Ointment

NET WT. 2 oz. (56g)

40% Zinc Oxide Skin Protectant

Helps Treat and Prevent Diaper Rash

INGREDIENTS AND APPEARANCE

DR. SHEFFIELD DIAPER RASH 
zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11527-058
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	400 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
COD LIVER OIL (UNII: BBL281NWFG)
LANOLIN (UNII: 7EV65EAW6H)
PETROLATUM (UNII: 4T6H12BN9U)
TALC (UNII: 7SEV7J4R1U)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11527-058-41	1 in 1 CARTON	01/09/2002
1		56 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 final	part347	01/09/2002

Labeler - Sheffield Pharmaceuticals LLC (151177797)

Establishment
Name	Address	ID/FEI	Business Operations
Sheffield Pharmaceuticals LLC		151177797	MANUFACTURE(11527-058)