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| Product NDC Code | 83520-107 | ||||
|---|---|---|---|---|---|
| Drug Name | Dermachange aid anti-itch |
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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 | M017 | ||||
| Labeler Name | Private Label Beauty and Wellness | ||||
| 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.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.Do not use more than directed. Adults and children 12 years of age and older, apply to the affected area not more than 3 to 4 times daily. Children under 12 years of age: ask a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Camphor, Citric Acid, Ethylhexylglycerin, Glycerin, Hydroxypropyl Methylcellulose, Phenoxyethanol, Propylene Glycol, SD Alcohol 38-B, Sodium Citrate, 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.For the temporary relief of pain and itching associated with insect bites, minor burns, sunburn, minor cuts, scrapes, minor skin irritations, and rashes due to poison ivy, oak, and sumac.
Purpose
Information about the drug product’s indications for use.Topical Analgesic.
Spl product data elements
Usually a list of ingredients in a drug product.Dermachange Aid Anti-Itch Diphenhydramine HCl CAMPHOR (SYNTHETIC) HYPROMELLOSES GLYCERIN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE ALCOHOL ETHYLHEXYLGLYCERIN WATER CITRIC ACID MONOHYDRATE PHENOXYETHANOL PROPYLENE GLYCOL SODIUM CITRATE
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.Label
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.If swallowed, get medical help or contact a Poison Control Center right away.
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, with any other products containing diphenhydramine, even one taken by mouth. When using this product avoid contact with eyes. Stop use and ask a doctor if condition worsens, if symptoms persist for more than 7 days or clear up and occur again within a few days.
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