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Itch Relief by Water-Jel Technologies, LLC.

Medically reviewed on November 1, 2017

Dosage form: spray
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 2g in 100mL
Labeler: Water-Jel Technologies, LLC.
NDC Code: 59898-810

Disclaimer: 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.

Itch Relief

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

ITCH RELIEF 
diphenhydramine hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUGItem 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
EDETATE DISODIUM (EDETIC ACID)  
HYPROMELLOSES 
OCTOXYNOL 9 
TROLAMINE 
GLYCERIN 
METHYLPARABEN 
PROPYLENE GLYCOL 
PROPYLPARABEN 
WATER 
DIAZOLIDINYL UREA 
Packaging
#Item CodePackage Description
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, LLC. (155522589)
Registrant - Water-Jel Technologies, LLC. (155522589)
Establishment
NameAddressID/FEIOperations
Water-Jel Technologies, LLC.155522589manufacture(59898-810)

 
Water-Jel Technologies, LLC.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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