TECNU IVY COMPLETE KIT- ivy treatment kit

Tecnu Ivy Complete Kit by

Drug Labeling and Warnings

Tecnu Ivy Complete Kit by is a Otc medication manufactured, distributed, or labeled by Tec Laboratories Inc., Tec Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Diphenhydramine HCL 2%

PURPOSE

Purpose Topical analgesic/antihistamine

INDICATIONS & USAGE

for the temporary relief of pain and itching associated with:

minor burnssunburnminor cutsscrapesinsect 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

ASK DOCTOR

Ask a doctor before use:

• on chicken pox
• on measles

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

WHEN USING

When using this product:

• avoid contact with eyes

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

QUESTIONS

Questions?

Call 1-800-482-4464

Serious side effects may be reported to this number

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TECNU IVY COMPLETE KIT 
ivy treatment kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51879-400

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51879-400-04	1 in 1 CARTON; Type 0: Not a Combination Product	01/16/2023

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE	113.4 g

Part 1 of 1

TECNU TREAT 
diphenhydramine hydrochloride gel

Product Information
Item Code (Source)	NDC: 51879-410
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	20 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ZINC ACETATE (UNII: FM5526K07A)
WATER (UNII: 059QF0KO0R)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
BENZETHONIUM CHLORIDE (UNII: PH41D05744)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
EDETATE DISODIUM (UNII: 7FLD91C86K)
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51879-410-04	113.4 g in 1 BOTTLE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/16/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/16/2023

Labeler - Tec Laboratories Inc. (083647792)

Establishment
Name	Address	ID/FEI	Business Operations
Tec Laboratories, Inc.		083647792	manufacture(51879-400)