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  5. Label Information: Rugby Barrier Cream

FDA Label for Rugby Barrier Cream

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. USES
    5. STOP USE AND CONSULT A DOCTOR •IN CASE OF BLEEDING •IF CONDITIONS WORSENOR DEOS NOT IMPROVE WITHIN 7 DAYS
    6. KEEP OUT OF REACH OF CHILDREN.
    7. DIRECTIONS
    8. OTHER INFORMATION
    9. INACTIVE INGREDIENTS
    10. PRINCIPAL DISPLAY PANEL - TUBE LABEL
    11. PRINCIPAL DISPLAY PANEL - CARTON

Rugby Barrier Cream Product Label

The following document was submitted to the FDA by the labeler of this product Rugby Laboratories. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



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. 


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



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 - Carton



NDC 0536-1204-73

Rugby

Menthol Zinc Ointment

Anorectal Cream  

0.45% Menthol

20% Zinc Oxide 

Net Wt. 4 oz 113 g 


* Please review the disclaimer below.