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| Product NDC Code | 77338-215 | ||||
|---|---|---|---|---|---|
| Drug Name | Astonea extra strength anti-itch cream itch stopping |
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| Type | Brand | ||||
| Pharm Class | Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| RxCUI drug identifier | 1087026 | ||||
| Application Number | M017 | ||||
| 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 ingredients Purpose Diphenhydramine hydrochloride 2% Topical analgesic Zinc acetate 0.1% Skin protectant
| Active ingredients | Purpose |
|---|---|
| Diphenhydramine hydrochloride 2% | Topical analgesic |
| Zinc acetate 0.1% | 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 adults and children 2 years of age and over: apply to affected area not more than 3 to 4 times daily children under 2 years of age: consult a physician
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Ceteth-20, Cetostearyl Alcohol, Chlorocresol, Edetate disodium, Light Mineral Oil, Petrolatum, Propylene Glycol, Sodium metabisulsulfite, 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 temporarily relieves pain and itching associated with: insect bites minor burns sunburn minor skin irritations minor cuts scrapes minor skin irritations rashes due to poison ivy, poison oak, oak, and sumac dries the oozing and weeping of poison ivy, poison oak, and poison sumac
Purpose
Information about the drug product’s indications for use.Active ingredients Purpose Diphenhydramine hydrochloride 2% Topical analgesic Zinc acetate 0.1% Skin protectant
| Active ingredients | Purpose |
|---|---|
| Diphenhydramine hydrochloride 2% | Topical analgesic |
| Zinc acetate 0.1% | Skin protectant |
Spl product data elements
Usually a list of ingredients in a drug product.ASTONEA Extra Strength Anti-Itch Cream Itch Stopping Diphenhydramine Hydrochloride and Zinc Acetate CHLOROCRESOL EDETATE SODIUM PROPYLENE GLYCOL WATER DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE ZINC ACETATE ZINC CATION SODIUM METABISULFITE CETETH-20 WHITE PETROLATUM LIGHT MINERAL OIL CETOSTEARYL ALCOHOL
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.ASTONEA Extra Strength Anti-Itch Cream 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
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.Ask a doctor before use on chicken pox on measles
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use on large areas of the body with any other product containing diphenhydramine, even one taken by mouth
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. (1-800-222-1222)
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 7 days symptoms persist for 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 use only as directed avoid contact with eyes
Storage and handling
Information about safe storage and handling of the drug product.Other information store at 20°C-25°C (68°C/77°F) do not use if tube seal under cap is broken
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 Do not use on large areas of the body with any other product containing diphenhydramine, even one taken by mouth Ask a doctor before use on chicken pox on measles When using this product use only as directed avoid contact with eyes Stop use and ask a doctor if condition worsens or does not improve within 7 days symptoms persist for 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. (1-800-222-1222)
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