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NDC 70000-0023-01 Itch Relief 20; 1 mg/mL; mg/mL Details

Itch Relief 20; 1 mg/mL; mg/mL

Itch Relief is a TOPICAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health, 110 dba Leader. The primary component is DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE.

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: 70000-0023-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Diphenhydramine

Product Information

NDC	70000-0023
Product ID	70000-0023_6cc51c6c-1c0d-4de7-92ab-27b00f98a667
Associated GPIs	90209902080920
GCN Sequence Number	060991
GCN Sequence Number Description	diphenhydramine HCl/zinc acet SPRAY 2 %-0.1 % TOPICAL
HIC3	L3P
HIC3 Description	ANTIPRURITICS,TOPICAL
GCN	27146
HICL Sequence Number	009759
HICL Sequence Number Description	DIPHENHYDRAMINE HCL/ZINC ACETATE
Brand/Generic	Generic
Proprietary Name	Itch Relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	Diphenhydramine HCl, Zinc Acetate
Product Type	HUMAN OTC DRUG
Dosage Form	SPRAY
Route	TOPICAL
Active Ingredient Strength	20; 1
Active Ingredient Units	mg/mL; mg/mL
Substance Name	DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE
Labeler Name	Cardinal Health, 110 dba Leader
Pharmaceutical Class	Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], 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 70000-0023-01 (70000002301)

Pricing Information
NDC Package Code	70000-0023-1
Billing NDC	70000002301
Package	59 mL in 1 BOTTLE, SPRAY (70000-0023-1)
Marketing Start Date	2011-08-02
NDC Exclude Flag	N
Price Per Unit	0.04549
Pricing Unit	ML
Effective Date	2023-12-20
NDC Description	ITCH RELIEF 2%-0.1% SPRAY
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	4, 5
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 3ed7b8a1-012f-459d-878c-813b93d4673c Details

Active ingredients

Diphenhydramine HCl 2%

Zinc Acetate 0.1%

Purpose

External analgesic

Skin protectant

Uses

for the temporary relief of pain and itching associated with minor skin irritations
dries the oozing and weeping of poison: ivy, oak, sumac

Warnings

For external use only

Flammable

Keep away from fire of flame.

Do not use

on large areas of the body
with any other product containing diphenhydramine, even one taken by mouth

Ask a doctor before use

on chicken pox or measles

When using this product

do not get into eyes

Stop use and ask a doctor if

condition worsens or 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.

Directions

do not use more than directed
adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
children under 2 years of age: ask a doctor

Other information

• store at 20⁰ - 25⁰C (68⁰ - 77⁰F)

Inactive ingredients

alcohol, glycerin, povidone, purified water, tris (hydroxymethyl)aminomethane

Questions & comments?

1-800-593-0593

Adverse reactions

Dist. by CAH, Dublin, OH 43017

2019 Cardinal Health

*This product is not manufactured or distributed by Johnson & Johnson Consumer Products Company of the registered trademark Benadryl Extra Strength Spray.

principal display panel

TEAR HERE

LEADER

NDC 70000-0023-1

Extra Strength

Itch Relief Spray

Diphenhydramine HCI, 2% Zinck Acetate, 0.1%

External Analgesic

Skin Protectant

COMPARE TO BENADRYL EXTRA STRENGTH SPRAY

active ingredients

100% Money Back Guarantee

Relieves Itching

Due to Insect Bits,

Poison Oak or Ivy, or Other Minor Skin Irritations

2 FL OZ (59 mL)

INGREDIENTS AND APPEARANCE

ITCH RELIEF

diphenhydramine hcl, zinc acetate spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0023
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	20 mg in 1 mL
ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37)	ZINC ACETATE	1 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
POVIDONE (UNII: FZ989GH94E)
WATER (UNII: 059QF0KO0R)
TROMETHAMINE (UNII: 023C2WHX2V)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70000-0023-1	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	08/02/2011

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	08/02/2011

Labeler - Cardinal Health, 110 dba Leader (063997360)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(70000-0023)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(70000-0023)

Revised: 11/2022

Document Id: 6cc51c6c-1c0d-4de7-92ab-27b00f98a667

Set id: 3ed7b8a1-012f-459d-878c-813b93d4673c

Version: 21

Effective Time: 20221110