FDA Label for Medline
View Indications, Usage & Precautions
Medline Product Label
The following document was submitted to the FDA by the labeler of this product Medline Industries, Lp. 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.
Active Ingredients
Menthol 0.44% w/w
White petrolatum 53% w/w
Zinc oxide 20.6% w/w
Purpose
Analgesic
Protectant
Protectant
Uses
- for the temporary relief of anorectal itching and discomfort in the perianal area associated with anorectal inflammation
- 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
Do Not Use On
- deep or puncture wounds
- animal bites
- serious burns
When Using This Product
- do not get into eyes
- 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 applicator
Stop Use And Ask A Doctor If
- condition worsens
- symptoms last more than 7 days or clear up and occur again within a few days
- in case of bleeding
Keep Out Of Reach Of Children.
In case of accidental ingestion, get medical help or contact a Poison Control Center right away.
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 the affected area up to 6 times daily
- Children under 12 years of age: consult a doctor
Other Information
- protect from freezing
- avoid excessive heat
- not made with Natural rubber Latex
Inactive Ingredients
7-dehydrocholesterol, algae extract (aphanizomenon flos-aquae), beeswax, bisabolol, brassica campestris (rapeseed) sterols, calamine, camellia sinensis (green tea) leaf extract, caprylic/capric triglycerides, carthamus tinctorius (safflower) seed oil, cetylhydroxyproline palmitamide, cholecalciferol, cocos nucifera (coconut) oil, dimethicone, eugenia caryophyllus (clove) flower extract, glycerin, hexyldecanol, hydrolyzed soy protein, manuka honey, olea europaea (olive) oil, phospholipids, phytonadione, simmondsia chinensis (jojoba) seed oil, stearic acid, tocopheryl acetate, water, yeast ferment extract, zea mays (corn) oil, zea mays (corn) starch.
Manufacturing Information
Manufactured for:
Medline Industries, LP
Three Lakes Drive, Northfield, IL 60093 USA
Made in USA of domestic and imported materials
1-800-MEDLINE (633-5463)
V1 RJ22PUA
REF: MSC092554PACK
Package Label
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