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| Product NDC Code | 67510-0054 | ||||||
|---|---|---|---|---|---|---|---|
| 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 | 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 adults and children 12 years of age and over: apply to affected area not more than 3 to 4 times daily children under 12 years of age: ask a doctor do not use more often than directed
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Cetyl alcohol, Glycerin, Glyceryl monostearate, levelling agent0, liquid paraffin, methylparaben, octadecyl alcohol, propyl 4-hydroxybenzoate, propylene glycol, purified water, stearic acid, vaseline
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 itching and pain associated with insect bites, minor skin irritations and 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.Purposes Topical analgesic Skin protectant
Spl product data elements
Usually a list of ingredients in a drug product.Anti Itch Diphenhydramine HCl, Zinc acetate ZINC ACETATE ZINC CATION DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE PARAFFIN CARBOMER HOMOPOLYMER TYPE C CETYL ALCOHOL GLYCERIN METHYLPARABEN GLYCERYL MONOSTEARATE STEARIC ACID PROPYLPARABEN WATER
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 chicken pox or measles with any other product containing diphenhydramine, even one taken by mouth on large areas of the body, including large areas of poison ivy, sunburn, or broken, blistered or oozing 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 If swallowed, get medical help or contact a Poison Control Center right away
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.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
Storage and handling
Information about safe storage and handling of the drug product.Other information store at 59° to 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 chicken pox or measles with any other product containing diphenhydramine, even one taken by mouth on large areas of the body, including large areas of poison ivy, sunburn, or broken, blistered or oozing skin 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