FDA.reportPublic FDA data

MMM Diaper Rash Cream

Manufacturer
Southern Sales & Services, Inc.
Effective date
2021-01-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:42:28

Label at a glance#

ProductMMM Diaper Rash Cream
Active ingredientZINC OXIDE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients Purpose

Zinc Oxide 5% Skin Protectant

OTC - PURPOSE SECTION

• Helps treat and prevent diaper rash.

• Protects chafed skin associated with diaper rash and helps protect from wetness.

WARNINGS SECTION

For external use only. When using this product avoid contact with eyes. Stop use and ask a doctor if

  • Condition worsens.
  • Symptoms last more than 7 days or clear up and occur again within a few days.

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

INDICATIONS & USAGE 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.

OTC - STOP USE SECTION

Stop use and ask a doctor if

• Condition worsens.
• Symptoms last more than 7 days or clear up and occur again within a few days.

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 INGREDIENT SECTION

Purified Water, cyclotetrasiloxane , Isopropyl palmitate, Ethylhexyl palmitate, Glycerin, Cyclopentasiloxane, Polyglyceryl-4 Isostearate, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Dimethicone, Tocopherol (Vitamin E), Zea Mays Oil, Retinyl palmitate(Vitamin A), Cholecalciferol (Vitamin D), Beeswax, Hydrogenated Castor Oil, Sodium Chloride, DMDM Hydantoin.

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

MMM Diaper Rash Cream

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MMM Diaper Rash CreamMMM Diaper Rash Cream

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
436525zinc oxide 5 % Topical CreamPSN1
436525zinc oxide 50 MG/ML Topical CreamSCD1
436525zinc oxide 5 % Topical CreamSY1
436525ZNO 50 MG/ML Topical CreamSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69822-007-602023-01-30C16284748780-1f386c649-e699-0266-e053-dadaa90a7c1aMMM Diaper Rash Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69822-007-60MMM Diaper Rash Cream170 g in 1 TUBECREAM1701

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69822-007MMM DIAPER RASH CREAM (ZINC OXIDE GEL) CREAM [SOUTHERN SALES & SERVICES, INC.]1Legacy NDC, 1 package rows20210923_cc86371a-cdea-10cb-e053-2a95a90a2357.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69822-00769822-007-60

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
CHOLECALCIFEROL1C6V77QF41IACT
HYDROGENATED CASTOR OILZF94AP8MEYIACT
DIMETHICONE92RU3N3Y1OIACT
TOCOPHEROLR0ZB2556P8IACT
HEXYL LAURATE4CG9F9W01QIACT
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)UF7620L1W6IACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
WATER059QF0KO0RIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
GLYCERINPDC6A3C0OXIACT
MONOPHENYLHEPTAMETHYLCYCLOTETRASILOXANE50Q464790PIACT
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7IACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5)V2W71V8T0XIACT
SODIUM CHLORIDE451W47IQ8XIACT
YELLOW WAX2ZA36H0S2VIACT
ZINC OXIDESOI2LOH54ZACTIB
DMDM HYDANTOINBYR0546TOWIACT
ETHYLHEXYL PALMITATE2865993309IACT

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
cc86371a-cdeb-10cb-e053-2a95a90a2357cc86371a-cdea-10cb-e053-2a95a90a23572021-01-01WarningsExact identifier
spl id: cc86371a-cdeb-10cb-e053-2a95a90a2357
spl set id: cc86371a-cdea-10cb-e053-2a95a90a2357

Reported adverse events (FAERS/openFDA)#

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