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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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105 Remedy Phytoplex Calazime

Active Ingredients

  • Menthol 0.44%
  • White Petrolatum 53%
  • Zinc Oxide 20.6%

Purpose

  • External Analgesic, Anti-itch
  • Protectant
  • Protectant

Uses

  • for the temporary relief of local itching and discomfort in the perianal area
  • temporarily protects irritated areas
  • for the temporary relief of pain
  • may provide a cooling sensation

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

  • adults: Cleanse the affected area by patting or blotting with an appropriate cleansing pad. Gently dry by patting or blotting with toilet tissue or a soft cloth. Apply product externally to the affected area up to 6 times daily.
  • children under 12 years of age: consult a doctor

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.

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)  
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)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
PHYTONADIONE (UNII: A034SE7857)  
YEAST (UNII: 3NY3SM6B8U)  
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
RAPESEED STEROL (UNII: B46B6DD20U)  
WATER (UNII: 059QF0KO0R)  
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 Product07/09/2018
2NDC:53329-105-96144 in 1 CARTON07/09/2018
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 Product07/09/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34707/09/2018
Labeler - Medline Industries (025460908)

Revised: 11/2020
 
Medline Industries