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Sudocrem skin protectant - Medication Information

Product NDC Code 84589-002
Drug Name

Sudocrem skin protectant

Type Brand
Active Ingredients
Zinc oxide 152.9 mg/g
Route TOPICAL
Dosage Form CREAM
Application Number M016
Labeler Name LEDA INNOVATIONS USA, INC.
Packages
Package NDC Code Description
84589-002-10 1 jar in 1 blister pack (84589-002-10) / 10 g in 1 jar
84589-002-12 125 g in 1 jar (84589-002-12)
84589-002-25 250 g in 1 jar (84589-002-25)
84589-002-40 400 g in 1 jar (84589-002-40)
84589-002-60 60 g in 1 jar (84589-002-60)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Zinc oxide (15.29%)

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 Apply as needed For diaper rash, change wet and soiled diapers promptly, cleanse the diaper area, and allow it to dry. Apply cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients beeswax, benzyl alcohol, benzyl benzoate, benzyl cinnamate, BHA, cetyl esters, cetyl alcohol, citric acid, lanolin, lavender oil, linalyl acetate, liquid paraffin, microcrystalline wax, paraffin wax, propylene glycol, sodium benzoate, sorbitan sesquioleate, stearic acid, 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 Diaper Rash and Incontinence Dermatitis Protects chafed skin and minor skin irritations due to diaper rash and helps protect from 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.
SUDOCREM SKIN PROTECTANT ZINC OXIDE WATER LANOLIN LINALYL ACETATE BENZYL CINNAMATE BENZYL BENZOATE SODIUM BENZOATE ZINC OXIDE ZINC OXIDE MICROCRYSTALLINE WAX PARAFFIN PROPYLENE GLYCOL BUTYLATED HYDROXYANISOLE YELLOW WAX BENZYL ALCOHOL LAVENDER OIL SORBITAN SESQUIOLEATE CITRIC ACID MONOHYDRATE STEARIC ACID CETYL ALCOHOL CETYL ESTERS WAX

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.
Product Packaging 1

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
Drug Facts

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

Other safety information

Information about safe use and handling of the product that may not have been specified in another field.
Other information Store at room temperature between 15C and 30C (59F to 86F) Do not use if safety seal is broken or missing

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 conditions worsens symptoms last more than 7 days or clear up and occur again within a few 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 do not get into eyes

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. When using this product do not get into eyes Stop use and ask a doctor if conditions worsens symptoms last more than 7 days or clear up and occur again within a few days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

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