FDA.reportPublic FDA data

BABY ANTI MONKEY BUTT DIAPER RASH

Manufacturer
Denison Pharmaceuticals, LLC.
Effective date
2017-01-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:53:56

Label at a glance#

ProductBABY ANTI MONKEY BUTT DIAPER RASH
Active ingredientZINC OXIDE, FERRIC OXIDE RED
Label structure12 sections

Indications and uses

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

Dosage and administration

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

Storage and handling

store at 20° to 27°C (68° to 80°F)

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 12.0%, Calamine Powder 2.0%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

  • helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash and 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 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 Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

STORAGE AND HANDLING SECTION

  • store at 20° to 27°C (68° to 80°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

allantoin, calendula extract, castor oil, dowicil, mineral oil, Peruvian balsam, white petrolatum

Questions?

OTC - QUESTIONS SECTION

Call 1-844-426-8465

BABY ANTI MONKEY BUTT DIAPER RASH (ZINC OXIDE, CALAMINE) CREAM

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0295-89420295-8942-46

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
FERRIC OXIDE RED1K09F3G675ACTIB
Allantoin344S277G0ZIACT
Calendula Officinalis Seed Oil9JS8DS42SVIACT
Castor OilD5340Y2I9GIACT
Mineral OilT5L8T28FGPIACT
Balsam Peru8P5F881OCYIACT
Petrolatum4T6H12BN9UIACT
Calendula Officinalis FlowerP0M7O4Y7YDIACT
GlycerinPDC6A3C0OXIACT
Water059QF0KO0RIACT

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
d7fea1da-e2f1-f24a-e053-2a95a90a80a3e581d0c8-113e-43f4-9ffa-ad804544fb4f2022-02-14WarningsExact identifier
spl set id: e581d0c8-113e-43f4-9ffa-ad804544fb4f

Reported adverse events (FAERS/openFDA)#

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