Tecnu Rash Relief by Tec Laboratories Inc.

Tecnu Rash Relief by

Drug Labeling and Warnings

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

Drug Details [pdf]

TECNU RASH RELIEF- diphenhydramine hydrochloride spray 
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%

Topical analgesic

Uses

temporary relieves the pain and itching associated with:

• sunburn
• minor skin irritations
• insect bites
• minor cuts, scrapes and burns

Warnings

For external use only

Do not use

• on large areas of the body
• with any other product containing diphenhydramine, even one taken by mouth

Ask a doctor before use

• on chicken pox
• on measles

Keep out of reach of children. If swallowed, get medical help or contact poison control right away.

Stop use and ask a doctor if

• conditions worsten
• symptoms persist for more than 7 days or clear up and occurs within a few days

Directions

• do not use more than directed
• adults and children 2 years of age and older; apply to affected area not more than 3 times daily
• children under 2 years of age: do not use, consult a doctor

Other information

store at room temperature (59-86°F/15-30°C)

bezethonium chloride

calendula officialis extract

disodium EDTA

glycerin

grindeila robusta extract

menthol

plantago major extract

polyoxyl 35 castor oil

purified water

SD alcohol

tea tree oil

white thyme oil

Questions? Call 1-800-482-4464

TECNU RASH RELIEF 
diphenhydramine hydrochloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51879-163
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
GRINDELIA HIRSUTULA FLOWERING TOP (UNII: IDB0NAZ6AI)
ALCOHOL (UNII: 3K9958V90M)
TEA TREE OIL (UNII: VIF565UC2G)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
PLANTAGO MAJOR (UNII: W2469WNO6U)
MENTHOL (UNII: L7T10EIP3A)
POLYOXYL 35 CASTOR OIL (UNII: 6D4M1DAL6O)
GLYCERIN (UNII: PDC6A3C0OX)
BENZETHONIUM CHLORIDE (UNII: PH41D05744)
WATER (UNII: 059QF0KO0R)
EDETATE DISODIUM (UNII: 7FLD91C86K)
THYME OIL (UNII: 2UK410MY6B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51879-163-06	177 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	11/17/2020	07/11/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	11/17/2020	07/11/2023

Labeler - Tec Laboratories Inc. (083647792)

Establishment
Name	Address	ID/FEI	Business Operations
Tec Laboratories Inc.		083647792	manufacture(51879-163)

Revised: 7/2023

Document Id: 0038fc61-8e8a-0d43-e063-6294a90a2abe

34390-5

Set id: b442ff7f-623b-5cc3-e053-2995a90a3094

Version: 3

Effective Time: 20230711