ITCH RELIEF- diphenhydramine hcl, zinc acetate spray
Cardinal Health, 110 dba Leader

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.

----------

Leader Itch Relief Spray 295.000/295AA-AB

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)

image description

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)

Revised: 6/2021

Document Id: 9c8f8bc9-b33c-42cc-a0d2-1dd1915cde94

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

Version: 20

Effective Time: 20210623

Cardinal Health, 110 dba Leader