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| Product NDC Code | 77338-050 | ||||
|---|---|---|---|---|---|
| Drug Name | Astonea 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 | OINTMENT | ||||
| RxCUI drug identifier | 1044412 | ||||
| Application Number | M016 | ||||
| Labeler Name | ASTONEA LABS PRIVATE LIMITED | ||||
| 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 (1.8% w/w) 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: Change wet or solied diapers promptly Clean diaper area with a mild cleanser, paying special attention to the perinium, buttocks, lower abdomen and inner thighs Allow to dry Apply to affected area as often as necessary or with each diaper change, especially at bedtime or any time 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), Cetostearyl Alcohol, Cholecalciferol (Vitamin D), Ethylhexylglycerine, FD&C Yellow No. 5, FD&C Yellow No. 6, Glycerin, Glyceryl Monostearate, Isopropyl Myristate, Lanolin, Lavender, Mineral Oil, Paraffin, Phenoxyethanol, Sodium Benzoate, 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 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.Astonea Skin Protectant ZINC OXIDE ETHYLHEXYLGLYCERIN VITAMIN A PALMITATE WATER ZINC OXIDE ZINC CATION GLYCERYL MONOSTEARATE SODIUM LAURETH-3 SULFATE FD&C YELLOW NO. 6 FOOD YELLOW 3 FREE ACID ISOPROPYL MYRISTATE LAVENDER OIL SODIUM BENZOATE FD&C YELLOW NO. 5 STEARIC ACID ALOE VERA LEAF ALPHA-TOCOPHEROL CETOSTEARYL ALCOHOL CHOLECALCIFEROL GLYCERIN LANOLIN MINERAL OIL PARAFFIN PHENOXYETHANOL
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: Principal Display and Drug Fact Panel
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
Other information: Store at room temperature 15º - 30ºC (59º - 86ºF) Avoid excessive heat
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 does not 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 When using this product Avoid contact with eyes If eye contact occurs, flush with water Stop use and ask a doctor if: Condition worsens or does not improve within seven 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