Menthol, Zinc Oxide, White Petrolatum

FDA Drug Profile — Zinc Oxide with Menthol and White Petrolatum

Drug Details

Generic Name
Menthol, Zinc Oxide, White Petrolatum
Brand Names
Zinc Oxide with Menthol and White Petrolatum
Application Number
M017
Sponsor
Aldermed Inc.
NDC Codes
1
Dosage Forms
OINTMENT
Routes
TOPICAL
Active Ingredients
MENTHOL, WHITE PETROLATUM, ZINC OXIDE

Indications and Usage

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

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)