ITCH RELIEF- diphenhydramine hydrochloride liquid

Itch Relief by

Drug Labeling and Warnings

Itch Relief by is a Otc medication manufactured, distributed, or labeled by 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 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 children If swallowed, get medical help or contact a poison control center right away.

Directions:

• 12 and over: apply to affected area not more than 3 to 4 times daily
• under 12: consult a doctor

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

INGREDIENTS AND APPEARANCE

ITCH RELIEF 
diphenhydramine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61010-8300
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: 61010-8300-1	0.0591 L in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	05/02/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/02/2013

Labeler - Safetec of America, Inc. (874965262)

Establishment
Name	Address	ID/FEI	Business Operations
Safetec of America, Inc.		874965262	MANUFACTURE(61010-8300)