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| Product NDC Code | 51879-802 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Tecnu calagel |
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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, 2174801 |
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| Application Number | M017 | ||||||||
| Labeler Name | Tec Laboratories 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.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 •do not use more often than directed •adults and children 2 years of age and older •cleanse skin with soap and warm water and dry affected area •apply to affected area not more than 3 times daily •may be covered with a sterile bandage, if bandaged, let dry first •children under 2 years of age do not use, consult a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.benzethonium chloride, disodium EDTA, fragrance, hypromellose, menthol, polysorbate 20, purified water, sodium metabisulfite, zinc acetate
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 temporary relief of pain and itching associated with: •minor burns •sunburn •minor cuts •scrapes •insect bites •minor skin irritations rashes due to: •poison oak •poison ivy •poison sumac
Purpose
Information about the drug product’s indications for use.Purpose Topical analgesic / antihistamine
Spl product data elements
Usually a list of ingredients in a drug product.Tecnu Calagel Diphenhydramine Hydrochloride POLYSORBATE 20 ZINC ACETATE HYPROMELLOSE 2208 (100 MPA.S) WATER MENTHOL, UNSPECIFIED FORM BENZETHONIUM CHLORIDE SODIUM METABISULFITE BISULFITE ION EDETATE DISODIUM EDETIC ACID 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.Calagel
Calagel POP
Calagel Dispenser
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.•on chicken pox •on 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.When using this product: •KEEP OUT OF REACH OF CHILDREN •if swallowed, get medical help or contact a poison control center right away •avoid contact with eyes
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call 1-800-482-4464 serious side effects may be reported to this number.
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 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 86ºF (15 to 30ºC)
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.DO NOT USE: •if allergic to sulfites •on children under 2 years of age unless directed by a doctor •with any other products containing diphenydramine, even one taken by mouth •on deep puncture wounds, animal bites or serious burns unless directed by a doctor •on large areas of the body
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