156 Remedy Specialized Zinc Oxide Paste

156 Remedy Specialized Zinc Oxide Paste
SPL v3
SPL
SPL Set ID 006539c9-1982-d6de-e063-6294a90a1a5a
Route
TOPICAL
Published
Effective Date 2023-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (206 mg) Menthol (4.4 mg) Petrolatum (530 mg)
Inactive Ingredients
Medium-chain Triglycerides Hydrolyzed Soy Protein (enzymatic; 2000 Mw) Phytonadione Yeast, Unspecified Corn Oil Alpha-tocopherol Acetate Cholecalciferol Coconut Oil Glycerin Hexyldecanol Honey Olive Oil Jojoba Oil Stearic Acid Water Green Tea Leaf Cetylhydroxyproline Palmitamide Aphanizomenon Flosaquae Yellow Wax Rapeseed Sterol Ferric Oxide Red Starch, Corn 7-dehydrocholesterol Levomenol Safflower Oil Dimethicone Clove

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-04-01

Description

Menthol 0.44% w/w White petrolatum 53% w/w Zinc oxide 20.6% w/w

Purpose

Analgesic Protectant Protectant


Medication Information

Purpose

Analgesic

Protectant

Protectant

Description

Menthol 0.44% w/w White petrolatum 53% w/w Zinc oxide 20.6% w/w

Uses

  • for the temporary relief of anorectal itching and discomfort in the perianal area associated with anorectal inflammation
  • temporarily forms a protective coating over inflamed tissues to help prevent drying of tissues
  • temporarily protects irritated areas
  • temporarily relieves burning
  • provides temporary relief from skin irritations
  • temporarily protects the inflamed irritated anorectal surface to help make bowel movements less painful
  • temporarily protects inflamed perianal skin
  • temporarily relieves the symptoms of perianal skin irritation
  • may provide a cooling sensation
Warnings

For external use only

Allergy Alert: 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, discontinue use and consult a doctor

Directions
  • adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. Apply to the affected area up to 6 times daily
  • Children under 12 years of age: consult a doctor

Do Not Use On
  • deep or puncture wounds
  • animal bites
  • serious burns
Package Label

Other Information
  • protect from freezing
  • avoid excessive heat
  • not made with Natural rubber Latex
Active Ingredients

Menthol 0.44% w/w

White petrolatum 53% w/w

Zinc oxide 20.6% w/w

Inactive Ingredients



7-dehydrocholesterol, algae extract (aphanizomenon flos-aquae), beeswax, bisabolol, brassica campestris (rapeseed) sterols, calamine, camellia sinensis (green tea) leaf extract, caprylic/capric triglycerides, carthamus tinctorius (safflower) seed oil, cetylhydroxyproline palmitamide, cholecalciferol, cocos nucifera (coconut) oil, dimethicone, eugenia caryophyllus (clove) flower extract, glycerin, hexyldecanol, hydrolyzed soy protein, manuka honey, olea europaea (olive) oil, phospholipids, phytonadione, simmondsia chinensis (jojoba) seed oil, stearic acid, tocopheryl acetate, water, yeast ferment extract, zea mays (corn) oil, zea mays (corn) starch.

When Using This Product
  • do not get into eyes
  • 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 applicator
Manufacturing Information

Manufactured for:

Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

Made in USA of domestic and imported materials

1-800-MEDLINE (633-5463)

REF: MSC092554PACK

Stop Use and Ask A Doctor If
  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days
  • in case of bleeding
Keep Out of Reach of Children.

In case of accidental ingestion, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses

  • for the temporary relief of anorectal itching and discomfort in the perianal area associated with anorectal inflammation
  • temporarily forms a protective coating over inflamed tissues to help prevent drying of tissues
  • temporarily protects irritated areas
  • temporarily relieves burning
  • provides temporary relief from skin irritations
  • temporarily protects the inflamed irritated anorectal surface to help make bowel movements less painful
  • temporarily protects inflamed perianal skin
  • temporarily relieves the symptoms of perianal skin irritation
  • may provide a cooling sensation
Purpose

Analgesic

Protectant

Protectant

Warnings

For external use only

Allergy Alert: 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, discontinue use and consult a doctor

Directions
  • adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. Apply to the affected area up to 6 times daily
  • Children under 12 years of age: consult a doctor

Do Not Use On (Do not use on)
  • deep or puncture wounds
  • animal bites
  • serious burns
Package Label

Other Information (Other information)
  • protect from freezing
  • avoid excessive heat
  • not made with Natural rubber Latex
Active Ingredients (Active ingredients)

Menthol 0.44% w/w

White petrolatum 53% w/w

Zinc oxide 20.6% w/w

Inactive Ingredients (Inactive ingredients)



7-dehydrocholesterol, algae extract (aphanizomenon flos-aquae), beeswax, bisabolol, brassica campestris (rapeseed) sterols, calamine, camellia sinensis (green tea) leaf extract, caprylic/capric triglycerides, carthamus tinctorius (safflower) seed oil, cetylhydroxyproline palmitamide, cholecalciferol, cocos nucifera (coconut) oil, dimethicone, eugenia caryophyllus (clove) flower extract, glycerin, hexyldecanol, hydrolyzed soy protein, manuka honey, olea europaea (olive) oil, phospholipids, phytonadione, simmondsia chinensis (jojoba) seed oil, stearic acid, tocopheryl acetate, water, yeast ferment extract, zea mays (corn) oil, zea mays (corn) starch.

When Using This Product (When using this product)
  • do not get into eyes
  • 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 applicator
Manufacturing Information (Manufacturing information)

Manufactured for:

Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

Made in USA of domestic and imported materials

1-800-MEDLINE (633-5463)

REF: MSC092554PACK

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days
  • in case of bleeding
Keep Out of Reach of Children. (Keep out of reach of children.)

In case of accidental ingestion, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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