Leader 295.000/295AB Itch Relief Spray

Manufacturer: Cardinal Health, 110 dba Leader | Nice-Pak Products, LLC
Effective date: 2026-08-06
Label type: HUMAN OTC DRUG LABEL
Version: 25
Source: daily-update
Hydrated at: 2026-08-08 02:00:57

Label at a glance#

ProductItch Relief

Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE

Label structure10 sections

Indications and uses

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

Dosage and administration

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

Storage and handling

• store at 20⁰ - 25⁰C (68⁰ - 77⁰F)

Contacts and useful links#

PhoneLabel contact1-888-593-0593

PhoneLabel contact1-800-200-5313

Websitewww.myleader.com

www.myleader.com

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 2%
Zinc Acetate 0.1%

Purpose

OTC - PURPOSE SECTION

External analgesic
Skin protectant

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only

Flammable

USER SAFETY WARNINGS SECTION

Keep away from fire of flame.

Do not use

OTC - DO NOT USE SECTION

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

Ask a doctor before use

OTC - ASK DOCTOR SECTION

on chicken pox or measles

When using this product

OTC - WHEN USING SECTION

do not get in eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

• store at 20⁰ - 25⁰C (68⁰ - 77⁰F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

1-888-593-0593

Adverse reactions

ADVERSE REACTIONS SECTION

Dist. by CAH, Dublin, OH 43017

www.myleader.com 1-800-200-5313

100% Money Back Guarantee

Return to place of purchase if not satisfied.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TEAR HERE

LEADER™

NDC 70000-0023-1

Extra Strength

Itch Relief Spray

Diphenhydramine HCI, 2%

Zinc Acetate, 0.1%

External Analgesic

Skin Protectant

2 FL OZ (59 mL)

CIN 5516091 Rev. 06/26

image descriptionimage description

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1053138	diphenhydrAMINE/Zinc acetate (Topical)	diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical Spray	SCD Active

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f47a510b-6679-4664-b2d6-47b5c4afe7cc	Product name	4	20260217
77dc03a4-fbfc-e6a3-fe95-285bbae40d75	Product name	2	20250814
030ce964-9b2d-45aa-b5d3-f78ce03ef61c	Product name	2	20250515
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
0306390c-dd77-4363-afe0-63c58088b2a1	Product name	1	20220120
503ea967-4b9c-48cf-9e87-c7975295849d	Product name	2	20220120
190f2a5b-bbc8-65c7-fcb0-97891307b917	Product name	1	20140508
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70000-0023-1	ML - Milliliter	70000-0023	01eb70ef-cd19-41c3-9016-31f24ae441ef	1	2019-11-12

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

Itch Relief
Diphenhydramine HCl, Zinc Acetate
DIPHENHYDRAMINE HYDROCHLORIDE
DIPHENHYDRAMINE
ZINC ACETATE
ZINC CATION
ALCOHOL
GLYCERIN
POVIDONE
WATER
TROMETHAMINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70000-0023	70000-0023-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DIPHENHYDRAMINE HYDROCHLORIDE	TC2D6JAD40	ACTIB
ZINC ACETATE	FM5526K07A	ACTIB
ALCOHOL	3K9958V90M	IACT
GLYCERIN	PDC6A3C0OX	IACT
POVIDONE	FZ989GH94E	IACT
WATER	059QF0KO0R	IACT
TROMETHAMINE	023C2WHX2V	IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
24	2026-01-29	full-release	2026-06-01 01:35:47

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Itch Relief	DIPHENHYDRAMINE HCL, ZINC ACETATE	Cardinal Health, 110 dba Leader	3ed7b8a1-012f-459d-878c-813b93d4673c	2026-08-06	Warnings, Adverse reactions	Exact identifier ndc (package): 70000-0023-1 ndc (product): 70000-0023 ndc11 (package): 70000002301 spl id: 5861fdab-c8ba-d81e-e063-6294a90af680 spl set id: 3ed7b8a1-012f-459d-878c-813b93d4673c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.