ITCH RELIEF- diphenhydramine hydrochloride liquid

Itch Relief by

Drug Labeling and Warnings

Itch Relief by is a Otc medication manufactured, distributed, or labeled by Cintas First Aid & Safety, Safetec of America, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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:

• do not use more than directed
• adults & children12 and over: apply to affected area not more than 3 to 4 times daily
• children under 12 years: consult a doctor

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

INGREDIENTS AND APPEARANCE

ITCH RELIEF 
diphenhydramine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68421-8300
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
diphenhydramine hydrochloride (UNII: TC2D6JAD40) (diphenhydramine - UNII:8GTS82S83M)	diphenhydramine hydrochloride	20.3 g  in 1 L

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68421-8300-0	0.0591 L in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	05/13/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/13/2013

Labeler - Cintas First Aid & Safety (056481716)

Registrant - Safetec of America, Inc. (874965262)

Establishment
Name	Address	ID/FEI	Business Operations
Safetec of America, Inc.		874965262	MANUFACTURE(68421-8300)