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REMEDY Calazime Skin Protectant

Medically reviewed on March 7, 2018

Dosage form: paste
Ingredients: FERRIC OXIDE RED 0.5g in 100g, MENTHOL 0.2g in 100g, PETROLATUM 69g in 100g, ZINC OXIDE 19.5g in 100g
Labeler: Medline Industries, Inc.
NDC Code: 53329-165

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

REMEDY Calazime Skin Protectant

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.

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)

REMEDY CALAZIME SKIN PROTECTANT 
calamine, menthol, white petrolatum, zinc oxide paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-165
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FERRIC OXIDE RED (FERRIC OXIDE RED) FERRIC OXIDE RED0.5 g  in 100 g
MENTHOL (MENTHOL) MENTHOL0.2 g  in 100 g
PETROLATUM (PETROLATUM) PETROLATUM69 g  in 100 g
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE19.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage Description
1NDC:53329-165-44113 g in 1 TUBE
2NDC:53329-165-96144 PACKET in 1 BOX
24 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/23/2012
Labeler - Medline Industries, Inc. (025460908)

 
Medline Industries, Inc.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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