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Product NDC Code | 69968-0061 | ||||||||||||||||
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Drug Name | Desitin maximum strength diaper rash |
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Type | Brand | ||||||||||||||||
Active Ingredients |
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Route | TOPICAL | ||||||||||||||||
Dosage Form | PASTE | ||||||||||||||||
RxCUI drug identifier | 1094560, 1797059 |
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Application Number | M016 | ||||||||||||||||
Labeler Name | Johnson & Johnson Consumer Inc. | ||||||||||||||||
Packages |
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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 cleanse the diaper area allow to dry apply paste 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 petrolatum, cod liver oil, lanolin, talc, glycerin, sorbitan sesquioleate, beeswax, tocopheryl acetate, fragrance
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 and 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.Desitin Maximum Strength Diaper Rash Zinc Oxide PETROLATUM COD LIVER OIL LANOLIN TALC GLYCERIN SORBITAN SESQUIOLEATE YELLOW WAX .ALPHA.-TOCOPHEROL ACETATE ZINC OXIDE ZINC OXIDE
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.PRINCIPAL DISPLAY PANEL - 113 g Tube Carton #1 CHOICE OF PEDIATRICIANS & MOMS Desitin ® Maximum Strength provides powerful, long-lasting relief • Paraben-free Zinc Oxide Diaper Rash Paste NET WT 4 Oz (113 g) PRINCIPAL DISPLAY PANEL - 113 g Tube Carton
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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
Distributed by: JOHNSON & JOHNSON CONSUMER INC. Skillman, NJ 08558
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.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
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? Call toll-free 800-720-3843 or 215-273-8755 (collect)
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°C to 25°C (68°F to 77°F) may stain clothing
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 condition 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