FDA.reportPublic FDA data

Kit containing diaper rash cream for 2016

Manufacturer
giggle
Effective date
2016-02-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:45:13

Label at a glance#

Productbody care gift set
Active ingredientZINC OXIDE
Label structure8 sections

Indications and uses

* Helps treat and prevent diaper rash * Protects chafed skin associated with diaper rash * Helps protect against wetness

Dosage and administration

* Change wet or soiled diaper 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 exposure to wet diapers may be prolonged.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide: 19%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

* Helps treat and prevent diaper rash
* Protects chafed skin associated with diaper rash
* Helps protect against wetness

Warnings

WARNINGS SECTION

For external use only.

OTC - WHEN USING SECTION

When using this product * avoid contact with eyes.

OTC - STOP USE SECTION

Stop use and ask a doctor if * condition worsens * symptoms last more than 7 days or clear up and return again within a few 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 or soiled diaper 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 exposure to wet diapers may be prolonged.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Helianthus Annuus (Sunflower) Seed Oil (1), Beeswax (1), Glyceryl Dibehenate, Tribehenin, Aloe Barbadensis Leaf Juice (1), Glyceryl Behenate, Tocopheryl Acetate, Carthamus Tinctorius (Safflower) Seed Oil (1), Olea Europae (Olive) Fruite Oil (1), Simmondsia Chinensis (Jojoba) Seed Oil (1), Calendula Officialis Flower Extract (1), Chamomilla Recutita (Matricaria) Flower Extract (1) (1) Certified Organic Ingredient

Questions?

OTC - QUESTIONS SECTION

Questions? Visit giggle.com or call 800-495-8577

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Body Care Gift SetBody Care Gift Set

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1739866zinc oxide 19 % Topical CreamPSN2
1739866zinc oxide 190 MG/ML Topical CreamSCD2
1739866zinc oxide 19 % Topical CreamSY2
1739866ZNO 190 MG/ML Topical CreamSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70306-9804-92020-01-31C16284748780-19d75b9d0-1efd-f424-e053-dadaa90a57ceKit containing diaper rash cream for 2016

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70306-1851-4body care gift set118 mL in 1 TUBECREAM118 mL19 g in 100mL2
70306-9804-9body care gift set1 in 1 KITKIT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70306-1851BODY CARE GIFT SET (ZINC OXIDE) KIT [GIGGLE]2Legacy NDC20160301_2b73aa6c-4c37-3b66-e054-00144ff88e88.zip
70306-9804BODY CARE GIFT SET (ZINC OXIDE) KIT [GIGGLE]2Legacy NDC, 2 package rows20160301_2b73aa6c-4c37-3b66-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70306-980470306-9804-9
70306-185170306-1851-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 36 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RINGR
CETYL ALCOHOL936JST6JCNINGR
GLYCERYL STEARATE SEFCZ5MH785IINGR
GLYCERINPDC6A3C0OXINGR
SUNFLOWER OIL3W1JG795YIINGR
COCONUT OILQ9L0O73W7LINGR
CASTOR OILD5340Y2I9GINGR
GREEN TEA LEAFW2ZU1RY8B0INGR
CHAMOMILEFGL3685T2XINGR
XANTHAN GUMTTV12P4NEEINGR
ALOE VERA LEAFZY81Z83H0XINGR
YELLOW WAX2ZA36H0S2VINGR
ANHYDROUS CITRIC ACIDXF417D3PSLINGR
CARNAUBA WAXR12CBM0EIZINGR
HYDROGENATED CASTOR OILZF94AP8MEYINGR
POTASSIUM SORBATE1VPU26JZZ4INGR
PHENOXYETHANOLHIE492ZZ3TINGR
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0INGR
CASTOR OILD5340Y2I9GINGR
COCONUT OILQ9L0O73W7LINGR
YELLOW WAX2ZA36H0S2VINGR
HYDROGENATED CASTOR OILZF94AP8MEYINGR
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0INGR
CHAMOMILEFGL3685T2XIACT
GLYCERYL MONOBEHENATEA626UU0W2AIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
ZINC OXIDESOI2LOH54ZACTIB
JOJOBA OIL724GKU717MIACT
YELLOW WAX2ZA36H0S2VIACT
GLYCERYL DIBEHENATER8WTH25YS2IACT
SAFFLOWER OIL65UEH262ISIACT
OLIVE OIL6UYK2W1W1EIACT
ALOE VERA LEAFZY81Z83H0XIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
SUNFLOWER OIL3W1JG795YIIACT
TRIBEHENIN8OC9U7TQZ0IACT

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
2b73aa6c-4c38-3b66-e054-00144ff88e882b73aa6c-4c37-3b66-e054-00144ff88e882016-02-18WarningsExact identifier
spl id: 2b73aa6c-4c38-3b66-e054-00144ff88e88
spl set id: 2b73aa6c-4c37-3b66-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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