MEDLINE REMEDY PHYTOPLEX CALAZIME- menthol, zinc oxide, petrolatum paste 
Medline Industries, LP

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105 Remedy Phytoplex Calazime

Active Ingredients

Purpose

Uses

Warnings

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

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

Protect from freezing. Avoid excessive heat.

Manufacturing Information

Manufactured for Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

www.medline.com

1-800-MEDLINE

REF: MSC092554

RH19PUA

Package Labels

Label 14

packet

box

Label 44

MEDLINE REMEDY PHYTOPLEX CALAZIME 
menthol, zinc oxide, petrolatum paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-105
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE20.6 g  in 100 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM53 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL44 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53329-105-44113 g in 1 TUBE; Type 0: Not a Combination Product07/09/201811/30/2025
2NDC:53329-105-96144 in 1 CARTON07/09/201812/31/2024
2NDC:53329-105-874 g in 1 PACKET; Type 0: Not a Combination Product
3NDC:53329-105-1457 g in 1 TUBE; Type 0: Not a Combination Product07/09/201805/31/2025
4NDC:53329-105-874 g in 1 PACKET; Type 0: Not a Combination Product07/09/201812/31/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01607/09/201811/30/2025
Labeler - Medline Industries, LP (025460908)

Revised: 1/2024
Document Id: 101b73d7-7130-311b-e063-6294a90afd67
Set id: 6dd75810-da93-28aa-e053-2a91aa0a0dab
Version: 7
Effective Time: 20240129
 
Medline Industries, LP