DR. SHEFFIELD BARRIER CREAM- barrier cream cream

Dr. Sheffield Barrier Cream by

Drug Labeling and Warnings

Dr. Sheffield Barrier Cream 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

Menthol 0.45%

Zinc Oxide 20%

Purpose

External Analgesic

Astringent

Uses

Multipurpose moisture barrier that aids in protecting irritated skin conditions in the perineum, buttocks, lower abdomen and inner thigh due to moisture, occlusion, chafing or continued contact with urine or feces.

Helps relieve the local itching, discomfort, pain, burning and irritation associated with anorectal disorders and hemorroids.May provide a cooling sensation. 

Warnings

For external use only

Stop use and consult a doctor 

in case of bleeding 

if conditions worsenor deos not improve within 7 days

<Do not exceed recommended daily dosage unless directed by a doctorDo not put prodcut into rectum by using fingers or any mechanical device or applicatorAllergy Alert:Certain persons can develop allergic reactions to this product. If the symptoms develop or increase,discontinue use and consult a doctor. >

Keep out of reach of children.

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

Directions

<Adults: When practical ,cleanse the affected areawith a mild soap and warm water and rinse thorughly. Gently dry by pattingor blotting with toilet tissue or a soft cloth beforeapplication of this product.Children under 12 years of age: consult a doctor. Apply extrenally to the affectedarea u pto 6 times a day.>

Other information

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

Inactive ingredients

Calamine, Codliver Oil, Disodium EDTA, Lanolin, Methylparaben, Microcrystalline Wax, Mineral Oil, Petrolatum, Propylparaben, Sodium Borate, Sorbitan Sequioleate, Talc, Water (Purified)

Principal Display Panel - Tube Label

NDC: 11527-213-22

Dr. Sheffield's

Made in the USA

Dual action Barrier Cream with pain relief

0.45% Menthol -External Analgesic 

20% Zinc Oxide -Astringent 

Protect and soothes irritated or chafed skin associated with incontinence 

Temporary relief of pain & itching

NET WT. 4 oz. (113g)

Principal Display Panel - Packet

NDC # 11527-213-75

Dr. Sheffield's  Made in the USA

Dual Action Barrier Cream with Pain Relief 

0.45% Menthol - External Analgesic

20% Zinc Oxide -Astrigent 

• Soothes and protects irritaed or chafed skin associated with incontinence 
• Temporarily relief of pain & itching

NET WT 4g( 1/7oz)

Principal Display Panel - Carton

NDC# 11527-213-75

Dr. Sheffield's  Made in the USA

Dual Action Barrier Cream 

0.45% Menthol

20% Zinc Oxide 

• Soothes and protects irritated or chafed skin associated with incontinence
• Provided temporary relief of pain & itching

1 GROSS ( 144pcs.)Net Wt. 4 g (1/7 oz) packets 

INGREDIENTS AND APPEARANCE

DR. SHEFFIELD BARRIER CREAM 
barrier cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11527-213
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
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	4.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
FERRIC OXIDE RED (UNII: 1K09F3G675)
COD LIVER OIL (UNII: BBL281NWFG)
DISODIUM ETHYLENEDIAMINEDIACETATE (UNII: EQL53S5L0F)
LANOLIN (UNII: 7EV65EAW6H)
METHYLPARABEN (UNII: A2I8C7HI9T)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM BORATE (UNII: 91MBZ8H3QO)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
TALC (UNII: 7SEV7J4R1U)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11527-213-22	113 g in 1 TUBE; Type 0: Not a Combination Product	02/28/2017
2	NDC: 11527-213-75	144 in 1 BOX	05/31/2017
2		4.0 g in 1 PACKET; 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	02/28/2017

Labeler - Sheffield Pharmaceuticals, LLC (151177797)

Establishment
Name	Address	ID/FEI	Business Operations
Sheffield Pharmaceuticals, LLC		151177797	MANUFACTURE(11527-213)