ITCH RELIEF- diphenhydramine hydrochloride liquid 
Cintas First Aid & Safety

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.

----------

Xpect First Aid ITCH RELIEF SPRAY
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 product containing 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 children If 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

Extra Strength

Itch Relief

Diphenhydramine HCl 2%

Quick itch and pain relief.
Use as a first aid
treatment for insect bites
and rashes from poison
ivy, oak & sumac.
Convenient pump spray
allows no-touch
application.

2 fl. oz. (59.1ml)

Xpect First Aid

PRINCIPAL DISPLAY PANEL
ITCH RELIEF 
diphenhydramine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68421-8300
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:68421-8300-00.0591 L in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/13/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/13/2013
Labeler - Cintas First Aid & Safety (056481716)
Registrant - Safetec of America, Inc. (874965262)
Establishment
NameAddressID/FEIBusiness Operations
Safetec of America, Inc.874965262MANUFACTURE(68421-8300)

Revised: 5/2013
Document Id: 34310875-b4c0-4ee6-aa05-3c07dbdfca4b
Set id: fdcec01b-e4fe-4440-b6e1-572a13c49661
Version: 3
Effective Time: 20130513
 
Cintas First Aid & Safety