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  5. Label Information: Remedy Calazime Skin Protectant

FDA Label for Remedy Calazime Skin Protectant

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. WHEN USING THIS PRODUCT
    7. STOP USE AND ASK A DOCTOR IF
    8. KEEP OUT OF REACH OF CHILDREN.
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. OTHER
    13. PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Remedy Calazime Skin Protectant Product Label

The following document was submitted to the FDA by the labeler of this product Medline Industries, Lp. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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.