ITCH RELIEF- diphenhydramine hydrochloride spray 
Water-Jel Technologies, LLC.

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.

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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

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 • condition clears up and occurs again within 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, trolamine, water

Questions or comments?

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

Manufactured by Water-Jel Technologies Inc.

50 Broad Street, Carlstadt, NJ 07072

Principal Display Panel

AI2

ITCH RELIEF 
diphenhydramine hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59898-810
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59898-810-1059 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product09/25/2010
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/FEIBusiness Operations
Water-Jel Technologies, LLC.155522589manufacture(59898-810)

Revised: 12/2020
Document Id: b70f3703-29da-94b4-e053-2a95a90a8bb9
Set id: 98b35828-912c-4d08-b5b2-4829aee85742
Version: 4
Effective Time: 20201222
 
Water-Jel Technologies, LLC.