Your browser does not support JavaScript! ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) SPRAY [WATER-JEL TECHNOLOGIES]
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ITCH RELIEF (diphenhydramine hydrochloride) spray
[Water-Jel Technologies]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

Active ingredient

Diphenhydramine hydrochloride 2%

Purpose

External analgesic

Uses

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

Warnings

For external use only

Do not use

  • on poison ivy or sunburn
  • on broken, blistered or oozing skin
  • on large areas of the body
  • with any other product containing diphenhydramine, even one taken by mouth

Ask a doctor before use

  • on chicken pox or measles

Stop use and ask a doctor if

  • condition worsens
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days

Keep out of the reach of children

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

Directions

  • do not use more often than directed
  • adults and children 2 years of age and older: apply to the affected area not more than 3 - 4 times daily
  • children under 2 years: consult a doctor

Other information

  • store at room temperature

Inactive ingredients

diazoldinyl 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

image of PDP

ITCH RELIEF 
diphenhydramine hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:59898-810
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Diphenhydramine Hydrochloride (Diphenhydramine ) Diphenhydramine Hydrochloride2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
DIAZOLIDINYL UREA 
EDETATE DISODIUM 
HYPROMELLOSE 
METHYLPARABEN 
OCTOXYNOL 9 
PROPYLENE GLYCOL 
PROPYLPARABEN 
WATER 
TROLAMINE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59898-810-1059 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/25/2010
Labeler - Water-Jel Technologies (155522589)
Registrant - Water-Jel Technologies (155522589)
Establishment
NameAddressID/FEIBusiness Operations
Water-Jel Technologies155522589manufacture

Revised: 9/2010
 
Water-Jel Technologies

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