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| Product NDC Code | 63868-260 | ||||
|---|---|---|---|---|---|
| Drug Name | Itch stopping |
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| Type | Brand | ||||
| Pharm Class | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 1049880 | ||||
| Application Number | part348 | ||||
| Labeler Name | Chain Drug Marketing Association | ||||
| 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%............................................................................................... Topical analgesic
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.dosage and administration adults and children 2 years and older: apply to affected area not more than 3 to 4 times daily children under 2 years: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients camphor, citric acid, diazolidinyl urea, hypromellose, methylparaben, propylene glycol, propylparaben, purified water, SD alcohol 40-B, sodium citrate
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 temporary relieves pain and itching due to: insect bites minor burns sunburn minor skin irritations minor cuts scrapes rashes due to poison ivy, poison oak, and poison sumac
Purpose
Information about the drug product’s indications for use.Purpose Anti itch
Spl product data elements
Usually a list of ingredients in a drug product.Itch Stopping Diphenhydramine HCl DIAZOLIDINYL UREA METHYLPARABEN TRISODIUM CITRATE DIHYDRATE ALCOHOL WATER PROPYLENE GLYCOL ANHYDROUS CITRIC ACID HYPROMELLOSE 2910 (4000 MPA.S) CAMPHOR (SYNTHETIC) PROPYLPARABEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE
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 Dipslay label Quality Choice QC Compare to the active ingredient in Benadryl Gel Extra strength Itch Relief Gel Topical Analgesic Diphenhydramine HCL 2% For skin use only QC choice Gel .jpg
Ask doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.Ask Doctor Before Use On chiken 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.
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 Doctor if condition worsens symptoms last 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 do not get into eyes
Storage and handling
Information about safe storage and handling of the drug product.Other store at 20 °C to 25 °C (68 °F 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 large areas of the body with any other product containing diphenhydramine, even one taken by mouth Ask Doctor Before Use On chiken Pox On Measles When Using This Product do not get into eyes Stop Use and ask Doctor if condition worsens symptoms last 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