FDA.reportPublic FDA data

CAREALL Anti-Itch

Manufacturer
New World Imports, Inc
Effective date
2025-12-01
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:18:44

Label at a glance#

ProductCAREALL Anti-Itch
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE
Label structure8 sections

Indications and uses

Uses temporarily relieves pain and itching associated with: insect bites, minor burns, sunburn, minor skin irritations, minor cuts, scrapes, rashes due to poison ivy / poison oak / poison sumac. dries the oozing and weeping of poison ivy, poison oak and poison 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

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine Hydrochloride 2%

Zinc Acetate 0.1%

Purpose

OTC - PURPOSE SECTION

Diphenhydramine Hydrochloride 2%....Topical Analgesic

Zinc Acetate 0.1%.............................Skin Protectant

Keep out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

Uses

INDICATIONS & USAGE SECTION

Uses

  • temporarily relieves pain and itching associated with: insect bites, minor burns, sunburn, minor skin irritations, minor cuts, scrapes, rashes due to poison ivy / poison oak / poison sumac.
  • dries the oozing and weeping of poison ivy, poison oak and poison sumac.

Warnings

WARNINGS SECTION

For external use only.

Due 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
  • on measles

When using this productavoid contact with eyes

Stop use and ask a doctor if:

  • condition worsens or does not improve within 7 days
  • symptoms persists for more than 7 days or clear up and occur again within a few days

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

carbomer homopolymer type c, cetyl alcohol, glycerin, glyceryl monostearate, light mineral oil, methylparaben, polysorbate 60, propylparaben,  purified water, stearic acid

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Anti-itch CartonAnti-itch Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1087026diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical CreamPSN4
1087026diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical CreamSCD4
1087026diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical CreamSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130085317009250GTIN-13: 0085317009250
EAN-13: 0085317009250
GTIN-12: 085317009250
UPC-A: 085317009250
GTIN storage (14 digits): 00085317009250		AI125 Carton.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51824-088-01CAREALL Anti-Itch35 g in 1 TUBECREAM354

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51824-088-01GM - Gram51824-088e53bd25d-c3fd-4181-a7fd-adf37b3a0f5612023-07-06

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51824-08851824-088-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EIACT
CETYL ALCOHOL936JST6JCNIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
GLYCERINPDC6A3C0OXIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
LIGHT MINERAL OILN6K5787QVPIACT
POLYSORBATE 60CAL22UVI4MIACT
STEARIC ACID4ELV7Z65APIACT
WATER059QF0KO0RIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
ZINC ACETATEFM5526K07AACTIB

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
CAREALL Anti-ItchDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE CREAMNew World Imports, Inc3a01f57a-ebc6-4724-b625-1d1ea4b85e732025-12-01WarningsExact identifier
ndc (package): 51824-088-01
ndc (product): 51824-088
ndc11 (package): 51824008801
spl id: 44eb4ae2-989d-baba-e063-6394a90a39d2
spl set id: 3a01f57a-ebc6-4724-b625-1d1ea4b85e73

Reported adverse events (FAERS/openFDA)#

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