ITCH RELIEF- diphenhydramine hydrochloride liquid 
Safetec of America, Inc.

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61010-8300, Itch Relief Spray

Drug Facts

Active Ingredients

Diphenhydramine hydrochloride 2%

Purpose

External Analgesic

Uses:

For the temporary relief of pain and itching associated with minor skin irritations and rashes due to insect bites, poison oak and poison sumac.

Warnings

For external use only

Do not use

  • on large areas of the body
  • with any other products using diphenhydramine hydrochloride, even one taken by mouth

Ask a doctor before use

  • on chicken pox
  • on measles

When using this product

  • avoid contact with the eyes

Stop use and ask doctor if

  • condition worsens
  • symptoms persist more than 7 days or clear up and occur again within a few days

Keep out of reach of childrenIf swallowed, get medical help or contact a poison control center right away.

Directions:

Inactive Ingredients:

Germaben II, edetate disodium, glycerin, tomadol 25-9, purified water, triethanolamine

PRINCIPAL DISPLAY PANEL

NDC 61010-8300-1

Safetec

Diphenhydramine

Itch Relief Spray

Relief from pain and

itching due to insect

bites and rashes from

poison ivy, poison oak

and poison sumac.

Manufactured by

SAFETEC OF AMERICA, Inc.

Buffalo, NY 14215 800-456-7077

www.safetec.com

2 fl. oz. (59.1ml) Reorder no. 57001

PRINCIPAL DISPLAY PANEL
ITCH RELIEF 
diphenhydramine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61010-8300
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE20.3 g  in 1 L
Inactive Ingredients
Ingredient NameStrength
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
C12-15 PARETH-9 (UNII: H3ZIY6WP1R)  
WATER (UNII: 059QF0KO0R)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61010-8300-10.0591 L in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/02/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01705/02/2013
Labeler - Safetec of America, Inc. (874965262)
Establishment
NameAddressID/FEIBusiness Operations
Safetec of America, Inc.874965262manufacture(61010-8300)

Revised: 2/2024
Document Id: 109674e0-ef83-5844-e063-6394a90ae6b8
Set id: 4f4c801b-d894-4fa3-b024-6ca41a5f2a95
Version: 3
Effective Time: 20240204
 
Safetec of America, Inc.