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Product NDC Code | 52000-023 | ||||
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Drug Name | Anti-itch |
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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 | part348 | ||||
Labeler Name | Universal Distribution Center LLC | ||||
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 Diphenhydramine Hydrochloride 2% Zinc Acetate 0.1%
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 For children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. For children under 2 years of age: consult a physician.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Cetyl Alcohol, Diazolidinly urea, Methylparaben, Polyethylene Glycol Monostearate 1000, Propylene Gylcol, Propylparaben, Aloevera extract, Alpha-Tocopherol Acetate, Purified 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 For the temporary relief of pain and itching associated with: minor skin irritation allergic itches rashes hives minor burns insect bites poison ivy poison oak poison sumac
Purpose
Information about the drug product’s indications for use.Purpose Topical Analgesic Skin Protectant
Spl product data elements
Usually a list of ingredients in a drug product.Anti-Itch Diphenhydramine Hydrochloride and Zinc Acetate ALOE VERA LEAF .ALPHA.-TOCOPHEROL WATER CETYL ALCOHOL DIAZOLIDINYL UREA METHYLPARABEN PEG-20 STEARATE PROPYLENE GLYCOL PROPYLPARABEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE ZINC ACETATE 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.PRINCIPAL DISPLAY PANEL Anti-Itch Cream NET WT 1 OZ (28 g) image of package 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.Other information Store at 20ºC to 25ºC (68ºF to 77ºF).
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 children under 2 years of age. For external use only avoid contact with eyes do not apply to open wound or damaged skin.
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. In case of accidental ingestion, 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 symptoms persist for 7 days or clear up and occur again within a few days.
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
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