FDA.reportPublic FDA data

Pure Baby Diaper Rash Cream

Manufacturer
Fischer Pharmaceuticals Ltd
Effective date
2017-12-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:53:55

Label at a glance#

ProductPure Baby Diaper Rash
Active ingredientZinc Oxide
Label structure10 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 solid diapers promptly Clean 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 diaper may be prolonged.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 12%

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.

OTC - WHEN USING SECTION

When using this product avoid contact with the eyes.

OTC - STOP USE SECTION

Stop use and ask a doctor if condition worsens or lasts more than 7 days.

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 solid diapers promptly
  • Clean 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 diaper may be prolonged.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Bisabolol, Calendula Officinalis Flower Extract, Caprylic/Capric Triglyceride, Coco-Caprylate, Dunaliella Salina Extract, Ethylhexylglycerin, Globularia Alypum Leaf Extract, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Hydrogenated Castor Oil, Magnesium Sulfate, Olea Europaea (Olive) Fruit Oil, Phenoxyethanol, Polyglyceryl-2 Dipolyhydroxystearate, Polyglyceryl-3 Diisostearate, Potassium Sorbate, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Sodium Benzoate, Tocopherol, Water.

Questions or Comments?

OTC - QUESTIONS SECTION

Call 1-888-553-6112 Mon-Fri

SPL UNCLASSIFIED SECTION

Manufactured by:
Fischer Pharmaceuticals Ltd.
Tel Aviv, POB 39071, Israel.

PRINCIPAL DISPLAY PANEL - 113 g Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dr. Fischer®

Pure
baby

Diaper Rash Cream

100%
ORGANIC OILS

Helps Treat &
Prevent

With
Natural
Origin Ingredients

SCIENCE INSIDE
- SCIENCE INSIDE -

Hypoallergenic • Sensitive Tested

NO
Fragrance, Parabens, SLS, SLES,
Lanolin, Silicones, Paraffin, GMOs

Net Wt. 4 oz. (113 g.)

FISCHER PHARMACEUTICALS

PRINCIPAL DISPLAY PANEL - 113 g Tube Label
PRINCIPAL DISPLAY PANEL - 113 g Tube Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59886-414-322021-01-29C16284748780-1ba0f9c33-2ceb-a910-e053-dadaa90a0b85Pure Baby Diaper Rash Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59886-414-32Pure Baby Diaper Rash113 g in 1 TUBECREAM1132

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59886-414PURE BABY DIAPER RASH (ZINC OXIDE) CREAM [FISCHER PHARMACEUTICALS LTD]2Legacy NDC, 1 package rows20180101_8c0cbb66-38aa-4429-a6a0-6c063131296a.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59886-41459886-414-32

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
Zinc OxideSOI2LOH54ZACTIB
LEVOMENOL24WE03BX2TIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
Coco-Caprylate4828G836N6IACT
DUNALIELLA SALINAF4O1DKI9A6IACT
Ethylhexylglycerin147D247K3PIACT
GLOBULARIA CORDIFOLIA WHOLESD327VQ78HIACT
GlycerinPDC6A3C0OXIACT
SUNFLOWER OIL3W1JG795YIIACT
Hydrogenated Castor OilZF94AP8MEYIACT
MAGNESIUM SULFATE ANHYDROUSML30MJ2U7IIACT
OLIVE OIL6UYK2W1W1EIACT
PhenoxyethanolHIE492ZZ3TIACT
Polyglyceryl-2 Dipolyhydroxystearate9229XJ4V12IACT
Polyglyceryl-3 Diisostearate46P231IQV8IACT
Potassium Sorbate1VPU26JZZ4IACT
ALMOND OIL66YXD4DKO9IACT
Sodium BenzoateOJ245FE5EUIACT
TocopherolR0ZB2556P8IACT
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
17e936f0-b6f6-469b-b63b-eb410cd021c98c0cbb66-38aa-4429-a6a0-6c063131296a2017-12-28WarningsExact identifier
spl id: 17e936f0-b6f6-469b-b63b-eb410cd021c9
spl set id: 8c0cbb66-38aa-4429-a6a0-6c063131296a

Reported adverse events (FAERS/openFDA)#

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