RUGBY BARRIER CREAM- barrier cream cream 
Rugby Laboratories

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 doctor. Do not put product 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

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 0536-1204-73

Rugby

Menthol Zinc Ointment

Anorectal Cream 

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 - Tube Label

Principal Display Panel - Carton

Principal Display Panel - Carton

NDC 0536-1204-73

Rugby

Menthol Zinc Ointment

Anorectal Cream  

0.45% Menthol

20% Zinc Oxide 

Net Wt. 4 oz 113 g 

Principal Display Panel - Carton

RUGBY BARRIER CREAM 
barrier cream cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1204
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:0536-1204-731 in 1 CARTON05/06/2019
1113 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34705/03/2019
Labeler - Rugby Laboratories (079246066)
Registrant - Sheffield Pharmaceuticals, LLC (151177797)
Establishment
NameAddressID/FEIBusiness Operations
Sheffield Pharmaceuticals, LLC151177797MANUFACTURE(0536-1204)

Revised: 5/2019
Document Id: 8edb6351-974d-4b68-9353-bfba71a0d7d6
Set id: 5797b7b0-d5b2-41da-9825-245cc9b6f348
Version: 1
Effective Time: 20190503
 
Rugby Laboratories