Otc-Active Ingredient Section
Active Ingredient
Diphenylhydramine HCl 2%
Purpose
Topical analgesic/antihistamine
Tecnu Diphenhydramine Hcl Pain Relieving Anti Itch Gel 2% Gel
FDA Label NDC 0363-2785
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Walgreens for the product Tecnu Diphenhydramine Hcl Pain Relieving Anti Itch Gel 2% (NDC 0363-2785). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc-active ingredient section, uses, warnings section, otc-ask doctor section, otc when using this product, otc-stop using section, otc-keep out of reach of children section, indications & usage section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
Uses - for the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, minor skin irritations, rashes due ro poison ivy, poison oak, and poison sumac.
Warnings Section
Warnings
For external use only
Otc-Ask Doctor Section
OTC-Ask a doctor before use - on chicken pox, on measles
Otc When Using This Product
When using this product avoid contact with eyes
Otc-Stop Using Section
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
Otc-Keep Out Of Reach Of Children Section
OTC-Keep out of reach of children. If swollowed, get medical help or contact a poison control center right away
Indications & Usage Section
Indications & Usage
Other Information
Other information
Store at 59 to 86 degrees F (15 to 30 degrees C)
Inactive Ingredients
Inactive Ingredients
Benzothonium chloride, disodium EDTA, fragrance, hypromellose, menthol, polysorbate 20, purified water, sodium metabisulfite, zinc acetate
Otc-Questions Section
Questions? Call 1-800-4824464. Serious side effects may be reported to this number.
Purpose
Topical Analgesic/antihistamine
Directions
Do not use more often than directed
Adults and children 2 years and older
apply to the affected area not more than 3 times daily
Children under 2 years of age consult a doctor
Principal Display Panel
Tecnu Maximum Strength Treat
Diphenydramine 2%
Pain Relieving Anti-Itch Gel
Net Weight 4oz
* Please review the disclaimer below.
