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| Product NDC Code | 67510-0633 | ||||
|---|---|---|---|---|---|
| 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 | part347 | ||||
| Labeler Name | Kareway Product, 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 (in each gram) Diphenhydramine HCl 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 do not use more often than directed adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily children under 2 years of age: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients cetearyl alcohol, ethylparaben, glycerin, glyceryl stearate, mineral oil, polysorbate 80, propylene glycol, stearic acid, stearyl alcohol, 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 rashes due to poison ivy, poison oak or poison sumac dries the oozing and weeping of poison ivy, poison oak, and 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 HCl, Zinc acetate STEARYL ALCOHOL CETYL ALCOHOL GLYCERIN GLYCERYL 1-STEARATE MINERAL OIL ETHYLPARABEN POLYSORBATE 60 STEARIC ACID PROPYLENE GLYCOL WATER 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.Package label Anti-Itch Cream carton
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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or Comments? 1-800-883-0085
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 avoid contact with eyes
Storage and handling
Information about safe storage and handling of the drug product.Other information store at 20° - 25°C (68° - 77°F)
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 When using this product 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.
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