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| Product NDC Code | 82897-468 | ||||
|---|---|---|---|---|---|
| Drug Name | Max barrier skin protectant |
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| Type | Brand | ||||
| Pharm Class | Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| RxCUI drug identifier | 1305337 | ||||
| Application Number | M016 | ||||
| Labeler Name | GL HEALTH, INC. | ||||
| 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 ingredients Zinc Oxide 40% Purpose Skin Protectant
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 a layer of the skin protectant to the area you wish to protect. For diaper rash prevention, change wet & spoiled diapers immediately. Clean the diaper area & allow to dry. Apply cream liberally & as often as necessary with each diaper change, especially at bedtime or anytime when exposed to wet diapers for a long period of time.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Aloe Extract, Beeswax, Butyrospermum Parkii (Shea) Butter, Helianthus Annuus (Sunflower) Oil, Tocopheryl Acetate (Vitamin E)
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 Protects chafed skin due to wetness and helps seal out wetness Helps treat and prevent diaper rash
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.MAX BARRIER Skin Protectant ZINC OXIDE ALOE YELLOW WAX SHEA BUTTER HELIANTHUS ANNUUS FLOWERING TOP .ALPHA.-TOCOPHEROL ZINC OXIDE ZINC CATION
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 Labeling: Label
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 the reach of children If swallowed, get medical help or contact Poison Control Center (1-800-222-1222) immediately
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call 1-708-381-0334
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 talk to a doctor if condition worsens or does not improve after 7 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 the 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 avoid contact with the eyes Stop use and talk to a doctor if condition worsens or does not improve after 7 days Keep out of the reach of children If swallowed, get medical help or contact Poison Control Center (1-800-222-1222) immediately
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