REMEDY CALAZIME SKIN PROTECTANT- calamine, menthol, white petrolatum, zinc oxide paste

REMEDY Calazime Skin Protectant by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredient

Calamine 3.5%

Menthol 0.2%

White Petrolatum 69%

Zinc Oxide 16.5%

Purpose

Protectant

Protectant

Prot

Protectant

Uses

• Provides temporary relief from skin irritations, itching and discomfort in the perianal area
• For the temporary relief of pain
• May provide a cooling sensation

Warnings

For External Use Only

Do not use

• in the eyes
• on deep or puncture wounds
• on animal bites
• on serious burns.

When using this product

• 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 or applicator
• 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, stop use and consult a doctor

Stop use and ask a doctor if

• condition worsens or does not improved within 7 days
• you experience bleeding

Keep out of reach of children.

• If accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults

• Cleanse the affected area with Remedy No-rinse cleanser
• Gently dry
• Apply externally to the affected area up to 6 times daily
• For peri-G tubes, cleanse as directed, apply thin layer and secure with drain sponge or product as directed.

Children under 12 years of age

• Consult a doctor

Other information

• Protect from freezing, Avoid excessive heat.

Inactive ingredients

Aloe Barbadensis Leaf Juice, Ascorbic Acid, Ascorbyl Palmitate, Carthamus Tinctorius (Safflower) Seed Oil, Cholecalciferol, Citric Acid, Citrus Aurantium Dulcis Peel Oil, Citrus Grandis Peel Oil, Glycine, Helianthus Annuus (Sunflower) Seed Oil, Hydroxytyrosol, L-proline, L-taurine, Methylparaben, Modified Corn Starch, Methylsulfonymethane, N-acetyl-L-cysteine, Niacinamide, Olea Europaea (Olive) Fruit Oil, PEG-8, Pyridoxine Hydrochloride, Retinyl Palmitate, Tapioca Starch Polymethylsilsesquioxane, Tocopherol, Vanillin, Zea Mays (Corn) Oil.

SPL UNCLASSIFIED SECTION

Medline Remedy is a registered trademark of Medline Industries, Inc.
Olivamine is a registered trademark of McCord Research, Inc. Manufactured for
Medline Industries, Inc., Mundelein, IL 60060 www.medline.com
1-800-MEDLINE

Package/Label Principal Display Panel

N 53329-165-44

MEDLINE

REMEDY®

WITH OLIVAMINE®

CALAZIME®

SKIN PROTECTANT PASTE

Helps protect irritation and relieve pain associated with diaper rash. Nourishes skin.

NON-ALLERGENIC

NON-SENSITIZING

NET WT 4 oz (113 g)

INGREDIENTS AND APPEARANCE

REMEDY CALAZIME SKIN PROTECTANT 
calamine, menthol, white petrolatum, zinc oxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53329-165
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675)	FERRIC OXIDE RED	0.5 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.2 g  in 100 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	69 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	19.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
SAFFLOWER OIL (UNII: 65UEH262IS)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ORANGE OIL (UNII: AKN3KSD11B)
CITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44)
GLYCINE (UNII: TE7660XO1C)
SUNFLOWER OIL (UNII: 3W1JG795YI)
HYDROXYTYROSOL (UNII: QEU0NE4O90)
METHYLPARABEN (UNII: A2I8C7HI9T)
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
ACETYLCYSTEINE (UNII: WYQ7N0BPYC)
NIACINAMIDE (UNII: 25X51I8RD4)
OLIVE OIL (UNII: 6UYK2W1W1E)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
VANILLIN (UNII: CHI530446X)
CORN OIL (UNII: 8470G57WFM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53329-165-44	113 g in 1 TUBE; Type 0: Not a Combination Product	03/14/2018
2	NDC: 53329-165-96	144 in 1 BOX	03/14/2018
2		4 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	03/23/2012

Labeler - Medline Industries, Inc. (025460908)