Label: MEDLINE REMEDY PHYTOPLEX CALAZIME- menthol, zinc oxide, petrolatum paste
- NDC Code(s): 53329-105-14, 53329-105-44, 53329-105-87, 53329-105-96
- 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
- Uses
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Warnings
- For external use only
- Avoid contact with eyes
When using this product
- do not place into the rectum with fingers or any device or applicator
- keep out of reach of children
Stop use and ask a doctor if
- condition worsens or does not improve within 7 days
- bleeding occurs
- an allergic reaction develops with symptoms such as redness, irritation, or pain
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
- Do not exceed the recommended daily dosage unless directed by a doctor.
- Certain persons can develop allergic reactions to ingredients in this product. If the symptoms being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, discontinue use and consult a doctor.
- Directions
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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, corn starch, 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.
- Other information
- Manufacturing Information
- Package Labels
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INGREDIENTS AND APPEARANCE
MEDLINE REMEDY PHYTOPLEX CALAZIME
menthol, zinc oxide, petrolatum pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53329-105 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 20.6 g in 100 g PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 53 g in 100 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 44 g in 100 g Inactive Ingredients Ingredient Name Strength STEARIC ACID (UNII: 4ELV7Z65AP) OLIVE OIL (UNII: 6UYK2W1W1E) STARCH, CORN (UNII: O8232NY3SJ) HEXYLDECANOL (UNII: 151Z7P1317) .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) PHYTONADIONE (UNII: A034SE7857) YEAST (UNII: 3NY3SM6B8U) EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV) RAPESEED STEROL (UNII: B46B6DD20U) WATER (UNII: 059QF0KO0R) LEVOMENOL (UNII: 24WE03BX2T) CETYLHYDROXYPROLINE PALMITAMIDE (UNII: 74ONU0S62G) GREEN TEA LEAF (UNII: W2ZU1RY8B0) FERRIC OXIDE RED (UNII: 1K09F3G675) NORI (UNII: 477TV3P5UX) COCONUT OIL (UNII: Q9L0O73W7L) DIMETHICONE 100 (UNII: RO266O364U) HONEY (UNII: Y9H1V576FH) JOJOBA OIL (UNII: 724GKU717M) CHOLECALCIFEROL (UNII: 1C6V77QF41) CORN OIL (UNII: 8470G57WFM) HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6) 7-DEHYDROCHOLESTEROL (UNII: BK1IU07GKF) CAPRYLYL GLYCOL (UNII: 00YIU5438U) WHITE WAX (UNII: 7G1J5DA97F) SAFFLOWER OIL (UNII: 65UEH262IS) GLYCERIN (UNII: PDC6A3C0OX) CLOVE (UNII: K48IKT5321) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53329-105-44 113 g in 1 TUBE; Type 0: Not a Combination Product 07/09/2018 11/30/2025 2 NDC:53329-105-96 144 in 1 CARTON 07/09/2018 12/31/2024 2 NDC:53329-105-87 4 g in 1 PACKET; Type 0: Not a Combination Product 3 NDC:53329-105-14 57 g in 1 TUBE; Type 0: Not a Combination Product 07/09/2018 05/31/2025 4 NDC:53329-105-87 4 g in 1 PACKET; Type 0: Not a Combination Product 07/09/2018 12/31/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M016 07/09/2018 11/30/2025 Labeler - Medline Industries, LP (025460908)