Active Ingredient
Menthol 0.44%
Zinc Oxide 20.625%
White Petrolatum USP 66.625%
Zinc Oxide With Menthol And White Petrolatum Ointment
FDA Label NDC 87236-008
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Aldermed Inc. for the product Zinc Oxide With Menthol And White Petrolatum (NDC 87236-008). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, when using this product, stop use and ask a doctor if, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Analgesic
External Analgesic
Astringent/Protectant
Uses
■ gives temporary relief of local itching and discomfort in the perianal area
■ temporarily forms a protective coating over inflamed tissues to help prevent drying of tissues
■ temporarily protects irritated areas
■ temporarily relieves burning
■ provides temporary relief from skin irritations
■ temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful
■ temporarily protects inflamed perianal skin
■ temporarily relieves the symptoms of perianal skin irritation
■ may provide a cooling sensation
Warnings
For external use only
Allergy Alert: certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and consult a doctor.
When Using This Product
■ do not exceed the recommended daily dosage unless directed by a doctor
■ do not put this product into the rectum by using fingers or any mechanical device or applicator
Stop Use And Ask A Doctor If
■ condition worsens or does not improve in 7 days
■ bleeding occurs, consult a doctor promptly
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Directions
■ Adults: when practical cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. Apply to affected area up to 6 times daily.
■ Children under 12 years of age: consult a doctor
Other Information
• Store at room temperature 15°-30° C (59°-86° F)
Inactive Ingredients
Calamine, Glycerine, Lanolin, Mineral Oil, Phenol, Sodium Bicarbonate, Thymol
Questions?
Gopaldas Visram and Company Limited.
Address - A/327, TTC Industrial Area,
MIDC Mahape, Navi Mumbai,
Maharashtra 400710, India
* Please review the disclaimer below.
