DR. SHEFFIELD BARRIER CREAM- barrier cream cream 
Sheffield Pharmaceuticals, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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

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 - Tube Label

Principal Display Panel - Packet

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

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 
DR. SHEFFIELD BARRIER CREAM 
barrier cream cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11527-213
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE200 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11527-213-22113 g in 1 TUBE; Type 0: Not a Combination Product02/28/201704/30/2020
2NDC:11527-213-75144 in 1 BOX05/31/201704/30/2020
24.0 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34702/28/201704/30/2020
Labeler - Sheffield Pharmaceuticals, LLC (151177797)
Establishment
NameAddressID/FEIBusiness Operations
Sheffield Pharmaceuticals, LLC151177797MANUFACTURE(11527-213)

Revised: 9/2022
Document Id: 57af7d5f-70ee-4945-a9ef-f57dba6bf6b0
Set id: de3580fb-e167-4ee7-adc5-fe43ac10ae1d
Version: 2
Effective Time: 20220922
 
Sheffield Pharmaceuticals, LLC