Otc - Active Ingredient
Diphenhydramine HCL 2%
Tecnu Calagel
FDA Label NDC 51879-802
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Tec Laboratories Inc. for the product Tecnu Calagel (NDC 51879-802). 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, otc - purpose, indications & usage, warnings, otc - ask doctor, otc - keep out of reach of children, otc - stop use, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose Topical analgesic / antihistamine
Indications & Usage
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
Warnings
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
Otc - Ask Doctor
•on chicken pox •on measles
Otc - Keep Out Of Reach Of Children
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
Otc - Stop Use
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
Dosage & Administration
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
Storage And Handling
Other Information Store at 59 to 86°F (15 to 30°C)
Inactive Ingredient
benzethonium chloride, disodium EDTA, fragrance, hypromellose,
menthol, polysorbate 20, purified water, sodium metabisulfite, zinc acetate
Otc - Questions
Questions? Call 1-800-482-4464
serious side effects may be reported to this number.
Package Label.Principal Display Panel
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