TECNU IVY COMPLETE KIT- ivy treatment 
Tec Laboratories Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Diphenhydramine HCL 2%

Purpose Topical analgesic/antihistamine

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

Do not use:

Ask a doctor before use:

Keep out of reach of children.

When using this product:

Stop use and ask a doctor if:

Directions

Other information

Store at 59 to 86°F (15 to 30°C)

benzethonium chloride, disodium EDTA, fragrance, hypromellose, menthol, polysorbate 20, purified water, sodium metabisulfite, zinc acetate

Questions?

Call 1-800-482-4464

Serious side effects may be reported to this number

Ivy Complete Kit

TECNU IVY COMPLETE KIT 
ivy treatment kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51879-400
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51879-400-041 in 1 CARTON; Type 0: Not a Combination Product01/16/2023
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 113.4 g
Part 1 of 1
TECNU TREAT 
diphenhydramine hydrochloride gel
Product Information
Item Code (Source)NDC:51879-410
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51879-410-04113.4 g in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/16/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/16/2023
Labeler - Tec Laboratories Inc. (083647792)
Establishment
NameAddressID/FEIBusiness Operations
Tec Laboratories, Inc.083647792manufacture(51879-400)

Revised: 1/2023
Document Id: f047af5d-45d9-11ae-e053-2a95a90a2a22
Set id: f047af5d-45d8-11ae-e053-2a95a90a2a22
Version: 1
Effective Time: 20230103
 
Tec Laboratories Inc.