ITCH RELIEF- diphenhydramine hydrochloride spray

Itch Relief by

Drug Labeling and Warnings

Itch Relief by is a Otc medication manufactured, distributed, or labeled by Water-Jel Technologies, LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Diphenhydramine hydrochloride 2%

Purpose

External analgesic

Uses

for temporary relief of pain and itching associated with minor bums, minor cuts, scrapes, insect bites or minor skin irritations

Warnings

For external use only

Do not use

on large areas of the body

on broken, blistered or oozing skin on poison ivy or sunburn
more often than directed
wtth any other product containing diphenhydramlne, even one taken by mouth
on chicken pox or measles

When using this product

avoid contact with the eyes

Stop use and ask a doctor if

condition worsens symptoms persist for more than 7 days symptoms clear up and reoccur again in a few days

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

adults and children 2 years of age and older:

apply to affected area not more than 3-4 times daily

children under 2 years: consult a doctor

Other Information

store at room temperature
you may report a serious adverse reaction to this product to 1-800-275-3433

Inactive ingredients

diazolidinyl urea, edetate disodium, glycerin, hypromellose, methylparaben, octoxynol 9, propylene glycol, propylparaben. purified water, trolamine

Questions or comments?

1-800-275-3433
info@waterjel.com www.waterjel.com

Principal Display Panel

INGREDIENTS AND APPEARANCE

ITCH RELIEF 
diphenhydramine hydrochloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59898-810
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
EDETATE DISODIUM (UNII: 7FLD91C86K)
HYPROMELLOSES (UNII: 3NXW29V3WO)
OCTOXYNOL 9 (UNII: 7JPC6Y25QS)
TROLAMINE (UNII: 9O3K93S3TK)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59898-810-10	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	09/25/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/25/2010

Labeler - Water-Jel Technologies, LLC. (155522589)

Registrant - Water-Jel Technologies, LLC. (155522589)

Establishment
Name	Address	ID/FEI	Business Operations
Water-Jel Technologies, LLC.		155522589	manufacture(59898-810)