MedPath

Itch Relief

Meijer 295.000/295AA-AB Itch Relief Spray

Approved
Approval ID

e11390ec-99a3-4ff1-a3c8-ca909f4f67b5

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 11, 2025

Manufacturers
FDA

Meijer Distribution, Inc

DUNS: 006959555

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Diphenhydramine HCl, Zinc Acetate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code41250-295
Application NumberM017
Product Classification
M
Marketing Category
C200263
G
Generic Name
Diphenhydramine HCl, Zinc Acetate
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 11, 2025
FDA Product Classification

INGREDIENTS (7)

ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TROMETHAMINEInactive
Code: 023C2WHX2V
Classification: IACT
DIPHENHYDRAMINE HYDROCHLORIDEActive
Quantity: 20 mg in 1 mL
Code: TC2D6JAD40
Classification: ACTIB
ZINC ACETATEActive
Quantity: 1 mg in 1 mL
Code: FM5526K07A
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/11/2025

principal display panel

NDC 41250-295-20

TEAR HERE

COMPARE TO BENADRYL ®SPRAY ACTIVE INGREDIENTS*

meijer ®

Itch Relief Spray

TOPICAL ANALGESIC

SKIN PROTECTANT

Pain & Itch Reliever

2 FL OZ (59 mL)

image descriptionimage description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/11/2025

Uses

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

ADVERSE REACTIONS SECTION

LOINC: 34084-4Updated: 8/11/2025

Adverse Reactions

DIST. BY MEIJER DISTRIBUTION, INC.

GRAND RAPIDS, MI 49544

www.meijer.com

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/11/2025

Active ingredients

Diphenhydramine HCL 2%

Zinc acetate 0.1%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/11/2025

Purpose

External analgesic

Skin protectant

WARNINGS SECTION

LOINC: 34071-1Updated: 8/11/2025

Warnings

For external use only

Flammable. Keep away from fire or flame.

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 8/11/2025

Do not use

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

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 8/11/2025

Ask a doctor before use

  • on chicken pox or measles

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 8/11/2025

When using this product

do not get in eyes

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 8/11/2025

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 8/11/2025

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/11/2025

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

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 8/11/2025

Disclaimer

*THIS PRODUCT IS NOT MANUFACTURED OR DISTRIBUTED BY KENVUE, INC., DISTRIBUTOR OF BENADRYL ®EXTRA STRENGTH SPRAY.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/11/2025

Inactive ingredients

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

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Itch Relief - FDA Drug Approval Details