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NDC 63868-0260-04 Itch Stopping 2 g/100g Details

Itch Stopping 2 g/100g

Itch Stopping is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Chain Drug Marketing Association. The primary component is DIPHENHYDRAMINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Diphenhydramine is used to relieve red, irritated, itchy, watery eyes; sneezing; and runny nose caused by hay fever, allergies, or the common cold. Diphenhydramine is also used to relieve cough caused by minor throat or airway irritation. Diphenhydramine is also used to prevent and treat motion sickness, and to treat insomnia (difficulty falling asleep or staying asleep). Diphenhydramine is also used to control abnormal movements in people who have early stage parkinsonian syndrome (a disorder of the nervous system that causes difficulties with movement, muscle control, and balance) or who are experiencing movement problems as a side effect of a medication. Diphenhydramine will relieve the symptoms of these conditions but will not treat the cause of the symptoms or speed recovery. Diphenhydramine should not be used to cause sleepiness in children. Diphenhydramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.

Related Packages: 63868-0260-04
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Diphenhydramine

Diphenhydramine, an antihistamine, is used to relieve the itching of insect bites, sunburns, bee stings, poison ivy, poison oak, and minor skin irritation. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Related Packages: 63868-0260-04
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Diphenhydramine Topical

Product Information

NDC	63868-0260
Product ID	63868-260_b4e1fe4a-b0d9-ba31-e053-2a95a90a3692
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Itch Stopping
Proprietary Name Suffix	n/a
Non-Proprietary Name	Diphenhydramine HCl
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	2
Active Ingredient Units	g/100g
Substance Name	DIPHENHYDRAMINE HYDROCHLORIDE
Labeler Name	Chain Drug Marketing Association
Pharmaceutical Class	Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 63868-0260-04 (63868026004)

Pricing Information	N/A
NDC Package Code	63868-260-04
Billing NDC	63868026004
Package	113 g in 1 BOTTLE (63868-260-04)
Marketing Start Date	2014-05-14
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 884c9b47-d511-1d17-e053-2995a90a42eb Details

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	2 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63868-260-04	113 g in 1 BOTTLE; Type 0: Not a Combination Product	05/14/2014

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

Labeler - Chain Drug Marketing Association (011920774)

Registrant - Weeks & Leo (005290028)

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

Revised: 11/2020

Document Id: b4e1fe4a-b0d9-ba31-e053-2a95a90a3692

Set id: 884c9b47-d511-1d17-e053-2995a90a42eb

Version: 4

Effective Time: 20201124