Tecnu Calagel

Tecnu Calagel is an FDA-registered drug product whose active ingredient is DIPHENHYDRAMINE HYDROCHLORIDE. It is labelled by Tec Laboratories Inc. taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 51879-802, application M017, label effective 20260420. It is one of 66 FDA drug label records sharing the active ingredient DIPHENHYDRAMINE HYDROCHLORIDE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing DIPHENHYDRAMINE HYDROCHLORIDE are most often described in connection with: temporary relief, itching associated, minor burns, cuts scrapes, insect bites, skin irritations, rashes due, poison oak. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses 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

Directions Directions •do not use more often than directed •adults and children 2 years of age and older: apply to affected area not more than 3 times daily •children under 2 years of age do not use, consult a doctor

Warnings For external use only Do not use On chicken pox, poison ivy, sunburn, large areas of the body, broken, blistered, or oozing skin, more often than directed, or with any other product containing diphenhydramine, even one taken by mouth. When using this product avoid contact with eyes 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 Keep out of reach of children If swallowed, get medical help or contact a poison control ceneter right away.

FDA lists 66 drug label records with DIPHENHYDRAMINE HYDROCHLORIDE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is Tecnu Calagel used for?
Uses 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

Who makes Tecnu Calagel?
Tec Laboratories Inc. is the labeler of record for Tecnu Calagel. 66 FDA label records share the active ingredient DIPHENHYDRAMINE HYDROCHLORIDE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Tecnu Calagel come in?
administered by topical. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Tecnu Calagel prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing DIPHENHYDRAMINE HYDROCHLORIDE?
Yes. 66 FDA drug label records list DIPHENHYDRAMINE HYDROCHLORIDE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Tecnu Calagel been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.