Label: MEDLINE- menthol, white petrolatum, zinc oxide paste
- NDC Code(s): 53329-156-14, 53329-156-44, 53329-156-83, 53329-156-96
- Packager: Medline Industries, LP
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 29, 2024
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- Official Label (Printer Friendly)
- Active ingredients
- Purpose
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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
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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 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
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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
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Children under 12 years of age: consult a doctor
- Other information
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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
- Package Label
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INGREDIENTS AND APPEARANCE
MEDLINE
menthol, white petrolatum, zinc oxide pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53329-156 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 206 mg in 1 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 4.4 mg in 1 g PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 530 mg in 1 g Inactive Ingredients Ingredient Name Strength MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6) PHYTONADIONE (UNII: A034SE7857) YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U) CORN OIL (UNII: 8470G57WFM) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CHOLECALCIFEROL (UNII: 1C6V77QF41) COCONUT OIL (UNII: Q9L0O73W7L) GLYCERIN (UNII: PDC6A3C0OX) HEXYLDECANOL (UNII: 151Z7P1317) HONEY (UNII: Y9H1V576FH) OLIVE OIL (UNII: 6UYK2W1W1E) JOJOBA OIL (UNII: 724GKU717M) STEARIC ACID (UNII: 4ELV7Z65AP) WATER (UNII: 059QF0KO0R) GREEN TEA LEAF (UNII: W2ZU1RY8B0) CETYLHYDROXYPROLINE PALMITAMIDE (UNII: 74ONU0S62G) APHANIZOMENON FLOSAQUAE (UNII: 49VG1X560X) YELLOW WAX (UNII: 2ZA36H0S2V) RAPESEED STEROL (UNII: B46B6DD20U) FERRIC OXIDE RED (UNII: 1K09F3G675) STARCH, CORN (UNII: O8232NY3SJ) 7-DEHYDROCHOLESTEROL (UNII: BK1IU07GKF) LEVOMENOL (UNII: 24WE03BX2T) SAFFLOWER OIL (UNII: 65UEH262IS) DIMETHICONE (UNII: 92RU3N3Y1O) CLOVE (UNII: K48IKT5321) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53329-156-83 4 g in 1 PACKET; Type 0: Not a Combination Product 04/01/2023 2 NDC:53329-156-96 144 in 1 BOX 04/01/2023 2 NDC:53329-156-83 4 g in 1 PACKET; Type 0: Not a Combination Product 3 NDC:53329-156-14 57 g in 1 TUBE; Type 0: Not a Combination Product 01/01/2024 4 NDC:53329-156-44 113 g in 1 TUBE; Type 0: Not a Combination Product 01/01/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M015 04/01/2023 Labeler - Medline Industries, LP (025460908) Registrant - Medline Industries, LP (025460908)
