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| Product NDC Code | 59898-810 | ||||
|---|---|---|---|---|---|
| Drug Name | Itch relief |
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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 | SPRAY | ||||
| RxCUI drug identifier | 1050080 | ||||
| Application Number | part348 | ||||
| Labeler Name | Water-Jel Technologies, 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 ingredient Diphenhydramine hydrochloride 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 • adults and children 2 years of age and older: apply to affected area not more than 3-4 times daily • children under 2 years: consult a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients diazolidinyl urea, edetate disodium, glycerin, hypromellose, methylparaben, octoxynol 9, propylene glycol, propylparaben, trolamine, 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 temporary relief of pain and itching associated with minor bums, minor cuts, scrapes, insect bites or minor skin irritations
Purpose
Information about the drug product’s indications for use.Purpose External analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Itch Relief Diphenhydramine Hydrochloride EDETATE DISODIUM EDETIC ACID HYPROMELLOSES OCTOXYNOL 9 TROLAMINE GLYCERIN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN WATER DIAZOLIDINYL UREA
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 AI2
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 • on broken, blistered or oozing skin • on poison ivy or sunburn • more often than directed • wtth any other product containing diphenhydramlne, even one taken by mouth • on chicken pox or measles
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information • store at room temperature • you may report a serious adverse reaction to this product to 1-800-275-3433
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? 1-800-275-3433 [email protected] www.waterjel.com Manufactured by Water-Jel Technologies Inc. 50 Broad Street, Carlstadt, NJ 07072
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 more than 7 days • condition clears up and occurs again within 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 the eyes
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.For external use only Do not use • on large areas of the body • on broken, blistered or oozing skin • on poison ivy or sunburn • more often than directed • wtth any other product containing diphenhydramlne, even one taken by mouth • on chicken pox or measles When using this product avoid contact with the eyes Stop use and ask a doctor if • condition worsens • symptoms persist for more than 7 days • condition clears up and occurs again within 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