Remedy Calazime Skin Protectant Paste
FDA Label NDC 53329-165

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Medline Industries, Lp for the product Remedy Calazime Skin Protectant (NDC 53329-165). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.

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)

* Please review the disclaimer below.