ITCH STOPPING- diphenhydramine hcl gel

Itch Stopping by

Drug Labeling and Warnings

Itch Stopping by is a Otc medication manufactured, distributed, or labeled by Chain Drug Marketing Association, Weeks & Leo, weeks and Leo. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

ITCH STOPPING 
diphenhydramine hcl gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63868-260
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 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63868-260-04	113 g in 1 BOTTLE; Type 0: Not a Combination Product	05/14/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/14/2014

Labeler - Chain Drug Marketing Association (011920774)

Registrant - Weeks & Leo (005290028)

Establishment
Name	Address	ID/FEI	Business Operations
weeks and Leo		005290028	manufacture(63868-260)