FDA.reportPublic FDA data

Members Mark Diaper Rash

Manufacturer
Sams West Inc | Apollo Health and Beauty Care Inc.
Effective date
2018-03-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:54:58

Label at a glance#

ProductMembers Mark Diaper Rash
Active ingredientZINC OXIDE
Label structure8 sections

Indications and uses

helps treat and prevent diaper rash protects chafed skin due to diaper rash helps seal out wetness

Dosage and administration

change wet and soiled diapers promptly clean the diaper area and allow to dry apply ointment liberally as often as required with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

Storage and handling

store between 20°C - 25°C (68°F - 77°F)

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 13%

Purpose

OTC - PURPOSE SECTION

Skin protectant

Uses

INDICATIONS & USAGE SECTION

  • helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash
  • helps seal out wetness

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

Do not get into eyes.

Stop using this product 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.
Do not use on

OTC - DO NOT USE SECTION

  • deep puncture wounds
  • animal bites
  • serious burns
Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • change wet and soiled diapers promptly
  • clean the diaper area and allow to dry
  • apply ointment liberally as often as required with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

Other information

STORAGE AND HANDLING SECTION

store between 20°C - 25°C (68°F - 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Mineral Oil, Petrolatum, Beeswax, Dimethicone, Sorbitan Sesquioleate, Microcrystalline Wax, PEG-30 Dipolyhydroxystearate, Aloe Barbadensis Leaf Juice, Glycerin, Tropolone, Tocopheryl Acetate, Panthenol, 1,2-Hexanediol, Caprylyl Glycol, Magnesium Sulfate, Potassium Hydroxide.

Questions or comments?

OTC - QUESTIONS SECTION

1-888-301-0332

Label copy

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of the labelimage of the label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
349404zinc oxide 13 % Topical CreamPSN1
349404zinc oxide 130 MG/ML Topical CreamSCD1
349404zinc oxide 13 % Topical CreamSY1
349404ZNO 130 MG/ML Topical CreamSY1

DailyMed Pharmacologic Classes#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68196-002-072024-01-30C16284748780-11030e364-f909-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68196-002-07Members Mark Diaper Rash170 g in 1 TUBECREAM1701

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68196-002MEMBERS MARK DIAPER RASH (ZINC OXIDE) CREAM [SAMS WEST INC]1Legacy NDC, 1 package rows20180322_e656c7e7-5de4-4e3c-b714-bec2dd63a852.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
68196-00268196-002-07

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
ZINC OXIDESOI2LOH54ZACTIM
WATER059QF0KO0RIACT
MINERAL OILT5L8T28FGPIACT
PETROLATUM4T6H12BN9UIACT
YELLOW WAX2ZA36H0S2VIACT
DIMETHICONE92RU3N3Y1OIACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
PEG-30 DIPOLYHYDROXYSTEARATE9713Q0S7FOIACT
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
TROPOLONE7L6DL16P1TIACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
PANTHENOLWV9CM0O67ZIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
CAPRYLYL GLYCOL00YIU5438UIACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT

Source Document#

Source XML · Source PDF

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
bc083286-4393-46c8-ab75-04701d48f6c6e656c7e7-5de4-4e3c-b714-bec2dd63a8522018-03-21WarningsExact identifier
spl id: bc083286-4393-46c8-ab75-04701d48f6c6
spl set id: e656c7e7-5de4-4e3c-b714-bec2dd63a852

Reported adverse events (FAERS/openFDA)#

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