FDA.reportPublic FDA data

BABY DIAPER RASH CREAM

Manufacturer
Xtreme Tools International, Inc
Effective date
2024-12-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 20:43:55

Label at a glance#

ProductBABY Diaper Rash
Active ingredientZINC OXIDE
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 and 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 25°C (68° to 77°F) May stain clothing

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 17%

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 day

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Change wet and soiled diapers promptly
  • Cleanse the diaper area and 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 25°C (68° to 77°F)
  • May stain clothing

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Vegetable Oil (Olus Oil in the EU), Butyrospermum parkii (Shea Butter) Fruit, Cocos Nucifera (Coconut) Oil, Glycerin, Vitis Vinifera (Grape) Seed Oil, Aloe Barbadensis Leaf Extract, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Lavandula Angusfifolia (Lavender) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Anthemis Nobilis Flower extract, Shea Butter Ethyl Esters, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Hydrogenated Vegetable Oil, Heptyl Undecylenate, Polyglyceryl-2 Dipolyhydroxystearate, Cetearyl Alcohol, Polisorbate 60, Myrica Pubescens Fruit wax, Beeswax, Tocopheryl Acetate, Panthenol, Phenoxyethanol, Ethylhexylglycerin, Citric Acid

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-305-622-7474, Monday through Friday 9:00 AM to 5:00 PM

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

198 g in Jar; NDC 74553-002-01

creamcream

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74553-00274553-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
HEPTYL UNDECYLENATEW77QUB6GXOIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
JOJOBA OIL724GKU717MIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
ALOE VERA LEAFZY81Z83H0XIACT
ALMOND OIL66YXD4DKO9IACT
LAVENDER OILZBP1YXW0H8IACT
CHAMAEMELUM NOBILE FLOWERO2T154T6OGIACT
SHEA BUTTERK49155WL9YIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE9229XJ4V12IACT
GLYCERINPDC6A3C0OXIACT
GRAPE SEED OIL930MLC8XGGIACT
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RIACT
POLYSORBATE 60CAL22UVI4MIACT
MORELLA PUBESCENS FRUIT WAX2N43GS24LVIACT
YELLOW WAX2ZA36H0S2VIACT
PANTHENOLWV9CM0O67ZIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
COCONUT OILQ9L0O73W7LIACT
SHEA BUTTER ETHYL ESTERSV2CI786FPGIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT

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
38aebf58-6d58-4e28-b21e-84b3981889b3b0fd7fae-126f-34f3-e053-2995a90a30932025-03-12WarningsExact identifier
spl set id: b0fd7fae-126f-34f3-e053-2995a90a3093

Reported adverse events (FAERS/openFDA)#

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