Itch Relief (Diphenhydramine Hydrochloride) Liquid [Cintas First Aid & Safety] -

ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [CINTAS FIRST AID & SAFETY]
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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 - Bottle Label

Extra Strength
Itch Relief

Quick Itch & Pain Relief
Diphenhydramine HCl 2%

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

2 fl. oz. (59.1 mL)

Xpect®

First aid

INGREDIENTS AND APPEARANCE

ITCH RELIEF
diphenhydramine hydrochloride liquid

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

Ingredient Name	Strength
Inactive Ingredients
diazolidinyl urea (UNII: H5RIZ3MPW4)
edetate disodium (UNII: 7FLD91C86K)
glycerin (UNII: PDC6A3C0OX)
C12-15 PARETH-9 (UNII: H3ZIY6WP1R)
water (UNII: 059QF0KO0R)
trolamine (UNII: 9O3K93S3TK)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68421-8300-1	0.0591 L in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	05/13/2013

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

Labeler - Cintas First Aid & Safety (056481716)

Registrant - Safetec of America, Inc. (874965262)

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

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Medic