ITCH STOPPING- diphenhydramine hcl gel 
Chain Drug Marketing Association

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.

----------

Quality Choice Extra Strength Itch Stopping Gel

Active Ingredients

Diphenhydramine hydrochloride 2%............................................................................................... Topical analgesic

Uses

temporary relieves pain and itching due to:

insect bites

minor burns

sunburn

minor skin irritations

minor cuts

scrapes

rashes due to poison ivy, 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, even one taken by mouth

Ask Doctor Before Use

On chiken Pox

On Measles

When Using This Product

do not get into eyes

Stop Use and ask Doctor if

condition worsens

symptoms last 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.

Purpose

Anti itch

Directions

do not use more often than directed

adults and children 2 years and older: apply to affected area not more than 3 to 4 times daily

children under 2 years: ask a doctor

Other

store at 20 °C to 25 °C (68 °F to 77 °F)

Inactive Ingredients

camphor, citric acid, diazolidinyl urea, hypromellose, methylparaben, propylene glycol, propylparaben, purified water,
SD alcohol 40-B, sodium citrate

dosage and administration

adults and children 2 years and older: apply to affected area not more than 3 to 4 times daily

children under 2 years: ask a doctor

Principal Dipslay label

Quality Choice QC

Compare to the active ingredient in Benadryl Gel

Extra strength Itch Relief Gel

Topical Analgesic

Diphenhydramine HCL 2%

For skin use only

QC choice Gel .jpg

ITCH STOPPING 
diphenhydramine hcl gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-260
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
ALCOHOL (UNII: 3K9958V90M)  
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
HYPROMELLOSE 2910 (4000 MPA.S) (UNII: RN3152OP35)  
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63868-260-04113 g in 1 BOTTLE; Type 0: Not a Combination Product05/14/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/14/2014
Labeler - Chain Drug Marketing Association (011920774)
Registrant - Weeks & Leo (005290028)
Establishment
NameAddressID/FEIBusiness Operations
weeks and Leo005290028manufacture(63868-260)

Revised: 11/2020
Document Id: b4e1fe4a-b0d9-ba31-e053-2a95a90a3692
Set id: 884c9b47-d511-1d17-e053-2995a90a42eb
Version: 4
Effective Time: 20201124
 
Chain Drug Marketing Association