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| Product NDC Code | 0363-0353 | ||||
|---|---|---|---|---|---|
| Drug Name | Itch relief gel |
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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 | ||||
| Application Number | M017 | ||||
| Labeler Name | Walgreens | ||||
| 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 ingredient Diphenhydramine HCL 2%
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 Apply to affected area not more thatn 3 to 4 times daily
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients camphor, diazolidinyl urea, glycerin, hydroxypropyl methylcellulose, 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.Directions Do not use more than directed. Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.
Purpose
Information about the drug product’s indications for use.Purpose Topical Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Itch Relief Gel Diphenhydramine HCl WATER PROPYLENE GLYCOL GLYCERIN DIAZOLIDINYL UREA SODIUM CITRATE METHYLPARABEN PROPYLPARABEN CAMPHOR (SYNTHETIC) ALCOHOL HYPROMELLOSE 2208 (15000 MPA.S) DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE clear
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.Tube label Tube label
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
Stop use and ask a doctor if condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days
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
When using this product avoid contact with eyes
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? 1-800-925-4733
Storage and handling
Information about safe storage and handling of the drug product.Other information Store at room temperature
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.
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