FDA.reportPublic FDA data

Akin Diaper Rash

Manufacturer
Southern Sales & Service, Inc.
Effective date
2023-11-29
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:03:05

Label at a glance#

ProductAkin Diaper Rash
Active ingredientZINC OXIDE
Label structure8 sections

Indications and uses

Helps treat and prevent diaper rash Protects chafed skin associated with diaper rash and helps protect from wetness

Dosage and administration

Change wet and soiled diapers promptly. Cleanse the affected area, and allow to dry. Apply cream liberally as often as necessary, with each change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 5.0%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

  • Helps treat and prevent diaper rash
  • Protects chafed skin associated with diaper rash and helps protect from wetness

Warnings

WARNINGS SECTION

When using this product avoid contact with eyes.  For external use only. 

Stop use and ask a 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 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

Change wet and soiled diapers promptly. Cleanse the affected area, and allow to dry. Apply cream liberally as often as necessary, with each change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

Inactive ingredients

INACTIVE INGREDIENT SECTION

BeesWax, Butyrospermum parkii (shea) butter, Carbopol, Cetylstearyl alcohol, Cholecalciferol (Vitamin D), Citric Acid, Ciclopentasiloxane, cyclotetrasiloxane, Dimethicone, Disodium EDTA, DMDM Hydantoin, Ethylhexyl palmitate, Glycerin, Glycina Soja (soybean)oil, Isopropyl palmitate, PEG-40 Castor Oil, Purified Water, Retinyl palmitate (Vitamin A), Sodium Hydroxide, Tocopherol(Vitamin E).




Akin Diaper Rash Cream 170 g

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tube labelTube label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
436525zinc oxide 5 % Topical CreamPSN3
436525zinc oxide 50 MG/ML Topical CreamSCD3
436525zinc oxide 5 % Topical CreamSY3
436525ZNO 50 MG/ML Topical CreamSY3

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
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69822-003-06Akin Diaper Rash170 g in 1 TUBECREAM1703

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69822-003AKIN DIAPER RASH (ZINC OXIDE) CREAM [SOUTHERN SALES & SERVICE, INC.]3Current NDC, Legacy NDC, 1 package rows20231201_f5515517-7977-48f9-aab6-cf0d2f2a04a0.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69822-00369822-003-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
YELLOW WAX2ZA36H0S2VIACT
SHEA BUTTERK49155WL9YIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CHOLECALCIFEROL1C6V77QF41IACT
CITRIC ACID ACETATEDSO12WL7AUIACT
CYCLOMETHICONE 4CZ227117JEIACT
CYCLOMETHICONE 50THT5PCI0RIACT
DIMETHICONE92RU3N3Y1OIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
DMDM HYDANTOINBYR0546TOWIACT
ETHYLHEXYL PALMITATE2865993309IACT
GLYCERINPDC6A3C0OXIACT
SOYBEAN OIL241ATL177AIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
PEG-40 CASTOR OIL4ERD2076EFIACT
WATER059QF0KO0RIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
SODIUM HYDROXIDE55X04QC32IIACT
TOCOPHEROLR0ZB2556P8IACT
ZINC OXIDESOI2LOH54ZACTIM

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
Akin Diaper RashZINC OXIDESouthern Sales & Service, Inc.f5515517-7977-48f9-aab6-cf0d2f2a04a02023-11-29WarningsExact identifier
ndc (package): 69822-003-06
ndc (product): 69822-003
ndc11 (package): 69822000306
spl id: 0b57cdd0-d6fd-4e06-e063-6294a90a5af5
spl set id: f5515517-7977-48f9-aab6-cf0d2f2a04a0

Reported adverse events (FAERS/openFDA)#

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