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Ameriderm perishield - Medication Information

Product NDC Code 52410-8020
Drug Name

Ameriderm perishield

Type Brand
Active Ingredients
Zinc oxide 3.8 g/100g
Route TOPICAL
Dosage Form OINTMENT
RxCUI drug identifier 1089065
Application Number M016
Labeler Name Shield Line LLC
Packages
Package NDC Code Description
52410-8020-0 100 g in 1 tube (52410-8020-0)
52410-8020-4 452 g in 1 jar (52410-8020-4)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient Zinc Oxide 3.8%

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
Directions ■ Change wet and soiled diapers promptly ■ Clean diaper area with a mild cleanser, paying special attention to the perineum, buttocks,lower abdomen and inner thighs ■ Allow area to dry ■ Apply to affected area as often as necessary or with each diaper change, especially at bedtime or anytime when exposure to soiled diapers may be prolonged

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients Aloe Barbadensis Gel, Alpha Tocopherol (Vitamin E), Cholecalciferol (Vitamin D), Chloroxylenol, Cetostearyl Alcohol, Corn Oil, Ethylhexylglycerin, FD&C Yellow No. 5, FD&C Yellow No. 6, Fragrance, Glycerin, Glyceryl Monostearate, Isopropyl Myristate, Lanolin, Microcrystalline wax, Mineral Oil, Paraffin, Phenoxyethanol, Sodium Borate, Sodium Laureth-3 Sulfate, Stearic Acid, Vitamin A Palmitate, Water

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Uses ■ Helps treat and prevent rash associated with diaper rash,incontinence or exposure to feces and urine ■ Protects skin against irritation due to such rash and ■ Helps protect skin from exposure to wetness

Purpose

Information about the drug product’s indications for use.
Purpose Skin Protectant

Spl product data elements

Usually a list of ingredients in a drug product.
AmeriDerm PeriShield ZINC OXIDE FD&C YELLOW NO. 5 GLYCERYL MONOSTEARATE ALOE VERA LEAF CHLOROXYLENOL CHOLECALCIFEROL CORN OIL LANOLIN MINERAL OIL PARAFFIN PHENOXYETHANOL VITAMIN A PALMITATE SODIUM BORATE ALPHA-TOCOPHEROL ZINC OXIDE ZINC OXIDE ETHYLHEXYLGLYCERIN SODIUM LAURETH-3 SULFATE STEARIC ACID GLYCERIN CETOSTEARYL ALCOHOL MICROCRYSTALLINE WAX ISOPROPYL MYRISTATE WATER FD&C YELLOW NO. 6 FOOD YELLOW 3 FREE ACID

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Package Label Principal Display and Drug Fact Panel

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
Stop Use and ask a doctor if ■ condition worsens or doesn't improve within seven days

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.
When using this product ■ Avoid contact with eyes ■ If eye contact, occurs, flush with water

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Warnings For external use only

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API