MedPath

Itch Relief

Care One 295.000/295AB Itch Relief Spray

Approved
Approval ID

50153065-8511-404f-be47-55a14f2502f5

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jul 7, 2025

Manufacturers
FDA

Retail Business Services, LLC

DUNS: 967989935

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 Code72476-295
Application NumberM017
Product Classification
M
Marketing Category
C200263
G
Generic Name
Diphenhydramine HCl, Zinc Acetate
Product Specifications
Route of AdministrationTOPICAL
Effective DateJuly 7, 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: 7/7/2025

principal display panel

TEAR HERE

CAREONE ®

Itch Relief Spray

TOPICAL ANALGESIC

SKIN PROTECTANT

Pain and Itch Reliever

COMPARE TO THE ACTIVE INGREDIENTS IN BENADRYL ®SPRAY*

RELIEVES ITCHING DUE TO INSECT BITES, POISON OAK OR IVY, OR OTHER MINOR SKIN IRRITATIONS

OUR PHARMACISTS RECOMMEND

2 FL OZ (59 mL)

image descriptionimage description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 7/7/2025

Uses

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

ADVERSE REACTIONS SECTION

LOINC: 34084-4Updated: 7/7/2025

ADVERSE REACTION

DIST. BY FOODHOLD U.S.A., LLC

LANDOVER, MD 20785

1-877-846-9949 ©2021 Ahold Delhaize Licensing Sari

Quilty guaranteed or money back.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 7/7/2025

Active ingredients

Diphenhydramine HCl 2%
Zinc Acetate 0.1%

Purpose

External analgesic
Skin protectant

WARNINGS SECTION

LOINC: 34071-1Updated: 7/7/2025

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.

DOSAGE & ADMINISTRATION SECTION

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

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

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 7/7/2025

Other information

• store at 20⁰ to 25⁰C (68⁰ to 77⁰F)

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 7/7/2025

Inactive ingredients

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

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 7/7/2025

Disclaimer

*This product is not manufactured or distributed by Johnson & Johnson Consumer Products Company, distributor of Benadryl ®Spray.

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Itch Relief - FDA Drug Approval Details