Otc - Active Ingredient
Diphenhydramine HCL 2%
Tecnu Ivy Complete Kit
FDA Label NDC 51879-400
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 Ivy Complete Kit (NDC 51879-400). 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 - when using, otc - stop use, 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 the temporary relief of pain and itching associated with:
•minor burns•sunburn•minor cuts•scrapes•insect bites
•minor skin irritaitons
•rashes due to poison ivy, poison oak and poison sumac
Warnings
Do not use:
- on large areas of the body
- with any other product containing diphenhydramine, even on taken by mouth
Otc - Ask Doctor
Ask a doctor before use:
- on chicken pox
- on measles
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
- if swallowed, get medical help or contact a poison control center right away
Otc - When Using
When using this product:
- 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 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 bandage; if bandage 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
* Please review the disclaimer below.
