CareOne Extra Strength Itch Relief Continuous Spray

Manufacturer
Foodhold USA | Premier Brands of America Inc.
Effective date
2019-01-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:58:41

Label at a glance#

ProductDiphenhydramine HCI and Zinc Acetate
Active ingredientBROMODIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE
Label structure9 sections

Indications and uses

for the temporary relief of pain and itching associated with: minor burns sunburn minor cuts scrapes insect bites minor skin irritations rashes due to poison ivy, poison oak and poison sumac dries the oozing and weeping of poison ivy, poison oak and poison sumac

Dosage and administration

do not use more often 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

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCI 2.0%

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 burns
  • sunburn
  • minor cuts
  • scrapes
  • insect bites
  • minor skin irritations
  • rashes due to poison ivy, poison oak and poison sumac
  • dries the oozing and weeping of poison ivy, poison oak and poison sumac

Warnings

WARNINGS SECTION

For external use only.

Flammable:

SAFE HANDLING WARNING SECTION

Keep away from fire or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120ºF. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.

Do not use

OTC - DO NOT USE SECTION

  • on lare 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
  • on measles

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes

Stop use and ask doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

Keep out of the 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 often 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

OTHER SAFETY INFORMATION

store between 20º to 25ºC (68º to 77ºF)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf juice, glycerin, purified water, SD alcohol 40-B, tromethamine

Questions?

OTC - QUESTIONS SECTION

Call 1-866-964-0939

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CAREONE

Extra Strength Itch Relief Continuous Spray

Diphenhydramine Hydrochloride/

External Analgesic

Zinc Acetate / Skin Protectant

RELIEFS ITCHING FROM

INSECT BITES AND POISON

IVY, OAK & SUMAC

SOOTHES SUNBURN

AND MINOR BURNS & CUTS

NET WT 2.7 OZ (76g)

Careone Itch Relief Continuous SprayCareone Itch Relief Continuous Spray

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41520-090-76Diphenhydramine HCI and Zinc Acetate76 g in 1 CANISTERAEROSOL, SPRAY761

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-090DIPHENHYDRAMINE HCI AND ZINC ACETATE (ITCH RELIEF CONTINUOUS SPRAY) AEROSOL, SPRAY [FOODHOLD USA]1Legacy NDC, 1 package rows20190304_80ad4aca-9fb9-adeb-e053-2991aa0adf94.zip

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41520-09041520-090-76

Ingredients#

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

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

Source Document#

Source XML

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
80ad4aca-9fba-adeb-e053-2991aa0adf9480ad4aca-9fb9-adeb-e053-2991aa0adf942019-01-30WarningsExact identifier
spl id: 80ad4aca-9fba-adeb-e053-2991aa0adf94
spl set id: 80ad4aca-9fb9-adeb-e053-2991aa0adf94

Reported adverse events (FAERS/openFDA)#

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