FDA Label for Tecnu Calagel
View Indications, Usage & Precautions
Tecnu Calagel Product Label
The following document was submitted to the FDA by the labeler of this product Tec Laboratories Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Diphenhydramine HCL 2%
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.
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