REMEDY Calazime Skin Protectant description, usages, side effects, indications, overdosage, supplying and lots more!

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REMEDY Calazime Skin Protectant

Medline Industries, Inc.

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

Calamine 3.5%

Menthol 0.2%

White Petrolatum 69%

Zinc Oxide 20%

Purpose

Protectant

Analgesic

Protectant

Protectant

REMEDY Calazime Skin 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

REMEDY Calazime Skin Protectant 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.

Package/Label Principal Display Panel

MEDLINE

N 53329-165-44

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)

REMEDY Calazime Skin Protectant

REMEDY Calazime Skin Protectant

calamine, menthol, white petrolatum, zinc oxide PASTE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:53329-165
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ferric oxide red 0.5 g
MENTHOL 0.2 g
petrolatum 69 g
Zinc Oxide Zinc oxide 19.5 g

Inactive Ingredients

Ingredient Name Strength
Aloe Vera Leaf
ASCORBIC ACID
ASCORBYL PALMITATE
SAFFLOWER OIL
CHOLECALCIFEROL
CITRIC ACID MONOHYDRATE
ORANGE OIL
CITRUS MAXIMA FRUIT RIND OIL
glycine
SUNFLOWER OIL
HYDROXYTYROSOL
METHYLPARABEN
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)
DIMETHYL SULFONE
ACETYLCYSTEINE
NIACINAMIDE
olive oil
polyethylene glycol 400
PYRIDOXINE HYDROCHLORIDE
VITAMIN A PALMITATE
.ALPHA.-TOCOPHEROL
VANILLIN
CORN OIL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:53329-165-44 113 in 1 TUBE
2 4 in 1 PACKET
3 NDC:53329-165-96 144 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part346 2012-03-23


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