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| Product NDC Code | 63941-318 | ||||
|---|---|---|---|---|---|
| Drug Name | Diaper rash |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | part347 | ||||
| Labeler Name | Valu Merchandisers, Co. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Zinc Oxide 40%
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 the diaper area allow to dry apply cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime exposure to wet diapers may be prolonged
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients butylated hydroxytoluene, cod liver oil, fd&c yellow #4, lanolin, methyl paraben, paraffin wax, purified water, talc powder, white petrolatum
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 protects chafed skin due to diaper rash helps seal out 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.Diaper Rash Zinc Oxide BUTYLATED HYDROXYTOLUENE COD LIVER OIL LANOLIN METHYLPARABEN PETROLATUM TALC WATER ZINC OXIDE ZINC OXIDE PARAFFIN
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 Diaper Rash Cream carton
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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments ? Call toll free: 1-800-883-0085
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 symptoms last more than 7 days or clear up and occur 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
Storage and handling
Information about safe storage and handling of the drug product.Other information store at 20 to 25C (68 to 77F)
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 and/or intrarectal use only When using this product do not get into eyes Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur 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