165 remedy calazime skin protectant

165 remedy calazime skin protectant
SPL v9
SPL
SPL Set ID 1295cfcc-5b61-481b-964b-f53ffd0cb58e
Route
topical
Published
Effective Date 2016-02-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
ferric oxide red (0.5 g) menthol (0.2 g) zinc oxide (19.5 g) petrolatum (69 g)
Inactive Ingredients
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

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2012-03-23 Until 2023-12-13

Purpose

Protectant Protectant Prot Protectant

Description

Calamine 3.5% Menthol 0.2% White Petrolatum 69% Zinc Oxide 16.5%


Medication Information

Warnings

For External Use Only

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
Purpose

Protectant

Protectant

Prot

Protectant

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.

Description

Calamine 3.5% Menthol 0.2% White Petrolatum 69% Zinc Oxide 16.5%

Section 42229-5

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

Do Not Use
  • in the eyes
  • on deep or puncture wounds
  • on animal bites
  • on serious burns.
Package Label

Active Ingredient

Calamine 3.5%

Menthol 0.2%

White Petrolatum 69%

Zinc Oxide 16.5%

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.

Structured Label Content

Warnings

For External Use Only

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
Purpose

Protectant

Protectant

Prot

Protectant

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 (Other information)
  • Protect from freezing, Avoid excessive heat.
Inactive Ingredients (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.

Section 42229-5 (42229-5)

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

Do Not Use (Do not use)
  • in the eyes
  • on deep or puncture wounds
  • on animal bites
  • on serious burns.
Package Label

Active Ingredient (Active ingredient)

Calamine 3.5%

Menthol 0.2%

White Petrolatum 69%

Zinc Oxide 16.5%

When Using This Product (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 (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. (Keep out of reach of children.)
  • If accidentally swallowed, get medical help or contact a Poison Control Center right away.

Advanced Ingredient Data


Raw Label Data

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