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

Medline Remedy Phytoplex Calazime by

Drug Labeling and Warnings

Medline Remedy Phytoplex Calazime by is a Otc medication manufactured, distributed, or labeled by Medline Industries, LP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

MEDLINE REMEDY PHYTOPLEX CALAZIME 
menthol, zinc oxide, petrolatum paste

Product 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)
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 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
2	NDC: 53329-105-96	144 in 1 CARTON	07/09/2018
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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	07/09/2018

Labeler - Medline Industries (025460908)

Establishment
Name	Address	ID/FEI	Business Operations
UltraTab Laboratories		151051757	manufacture(53329-105)