FDA.reportPublic FDA data

babyganics ® diaper rash cream

Manufacturer
KAS Direct LLC dba BabyGanics
Effective date
2024-12-18
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 20:44:36

Label at a glance#

ProductBABYGANICS DIAPER RASH
Active ingredientZINC OXIDE
Label structure10 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 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 room temperature 59-77°F (15-25°C)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc oxide 15%

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

OTC - WHEN USING SECTION

When using this product 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

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
  • 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 room temperature 59-77°F (15-25°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, butyrospermum parkii (shea) butter, theobroma cacao (cocoa) seed butter, prunus amygdalus dulcis (sweet almond) oil, glycol stearate, simmondsia chinensis (jojoba) seed oil, polyglyceryl-3 polyricinoleate, glycerin, tocopheryl acetate, solanum lycopersicum (tomato) seed oil, helianthus annuus (sunflower) seed oil, vaccinium macrocarpon (cranberry) seed oil, nigella sativa (black cumin) seed oil, rubus idaeus (red raspberry) seed oil, calendula officinalis flower extract, aloe barbadensis leaf juice, sorbitan sesquioleate, cetyl ricinoleate, glyceryl caprate, beeswax, sodium polyacryloyldimethyl taurate, hydroxyethylcellulose, hydrogenated polydecene, trideceth-10, butylene glycol, magnesium stearate, aluminum tristearate, sodium benzoate, gluconolactone

SPL UNCLASSIFIED SECTION

Dist. by:
KAS Direct, LLC.
Hicksville, NY 11801

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ACCEPTED
e
NATIONALECZEMA.ORG

NATIONAL
ECZEMA
ASSOCIATION

babyganics™

diaper rash
cream

skin protectant

fragrance free • treats
& protects • helps
prevent diaper rash
promotes healing
non-allergenic
pediatrician &
dermatologist tested

formulated with:
zinc oxide*

formulated without:
parabens • phthalates
petroleum • mineral
oil • dyes or fragrances

Discover which of our
ingredients are
Certified Organic on
back panel.

Net wt 4 OZ (113 g)

Principal Display Panel - 113 g Tube Carton
Principal Display Panel - 113 g Tube Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59062-1219-12020-02-04C16284748780-19d75b9d0-eca4-f424-e053-dadaa90a57cebabyganics ® diaper rash cream
59062-1219-12020-01-31C16284748780-19d75b9d0-eca4-f424-e053-dadaa90a57cebabyganics ® diaper rash cream

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59062-1219BABYGANICS DIAPER RASH (ZINC OXIDE) CREAM [KAS DIRECT LLC DBA BABYGANICS]5Legacy NDC20241222_253c4065-bb58-413f-8ee4-dbd1576f33ae.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z2
ZINC OXIDEACTIVE MOIETYSOI2LOH54Z2
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L02
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X2
ALUMINUM STEARATEINACTIVE INGREDIENTU6XF9NP8HM2
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA2
CALENDULA OFFICINALIS FLOWERINACTIVE INGREDIENTP0M7O4Y7YD2
CETYL RICINOLEATEINACTIVE INGREDIENT1P677500YD2
CRANBERRY SEED OILINACTIVE INGREDIENT73KDS3BW5E2
GLUCONOLACTONEINACTIVE INGREDIENTWQ29KQ9POT2
GLYCERININACTIVE INGREDIENTPDC6A3C0OX2
GLYCERYL CAPRATEINACTIVE INGREDIENT197M6VFC1W2
GLYCOL STEARATEINACTIVE INGREDIENT0324G66D0E2
HYDROGENATED POLYDECENE (550 MW)INACTIVE INGREDIENTU333RI6EB72
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)INACTIVE INGREDIENTR33S7TK2EP2
JOJOBA OILINACTIVE INGREDIENT724GKU717M2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I302
NIGELLA SATIVA SEED OILINACTIVE INGREDIENTCS4U38E7312
POLYGLYCERYL-3 RICINOLEATEINACTIVE INGREDIENTMZQ63P0N0W2
RASPBERRY SEED OILINACTIVE INGREDIENT9S8867952A2
SHEANUT OILINACTIVE INGREDIENTO88E196QRF2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU2
SODIUM TAURATEINACTIVE INGREDIENTY7LJA74T0N2
SORBITAN SESQUIOLEATEINACTIVE INGREDIENT0W8RRI5W5A2
SUNFLOWER OILINACTIVE INGREDIENT3W1JG795YI2
TOMATO SEED OILINACTIVE INGREDIENT7N87T9C06T2
TRIDECETH-10INACTIVE INGREDIENTG624N6MSBA2
WATERINACTIVE INGREDIENT059QF0KO0R2
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2V2

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59062-121959062-1219-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RIACT
SHEANUT OILO88E196QRFIACT
GLYCOL STEARATE0324G66D0EIACT
JOJOBA OIL724GKU717MIACT
POLYGLYCERYL-3 RICINOLEATEMZQ63P0N0WIACT
GLYCERINPDC6A3C0OXIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TOMATO SEED OIL7N87T9C06TIACT
SUNFLOWER OIL3W1JG795YIIACT
CRANBERRY SEED OIL73KDS3BW5EIACT
NIGELLA SATIVA SEED OILCS4U38E731IACT
RASPBERRY SEED OIL9S8867952AIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
ALOE VERA LEAFZY81Z83H0XIACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
CETYL RICINOLEATE1P677500YDIACT
GLYCERYL 1-CAPRATE197M6VFC1WIACT
YELLOW WAX2ZA36H0S2VIACT
SODIUM TAURATEY7LJA74T0NIACT
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)R33S7TK2EPIACT
HYDROGENATED POLYDECENE TYPE IU333RI6EB7IACT
TRIDECETH-10G624N6MSBAIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
MAGNESIUM STEARATE70097M6I30IACT
ALUMINUM STEARATEU6XF9NP8HMIACT
SODIUM BENZOATEOJ245FE5EUIACT
GLUCONOLACTONEWQ29KQ9POTIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 180 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCONCENTRATE / ORAL20 mgExact identifier — unii candidate
35 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYSTEM / IONTOPHORESIS168.1 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CREAM / TOPICALNAExact identifier — unii candidate
39 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL / TOPICAL3 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / PERIODONTAL0.53 mgExact identifier — unii candidate
75 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30INSERT / VAGINAL69 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30WAFER / ORAL66 mgExact identifier — unii candidate
39 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / AURICULAR (OTIC)0.05 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL, FOAM / TOPICAL21 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUPPOSITORY / RECTAL440 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRAMUSCULAR450 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE / ORAL3822 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCREAM / TOPICAL0.2 %w/wExact identifier — unii candidate
35 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPONGE / TOPICAL2 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGEL / RECTAL406 mgExact identifier — unii candidate
35 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TRANSDERMAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
BUTYLENE GLYCOLBUTYLENE GLYCOL3XUS85K0RASYSTEM / TOPICAL1400 mgExact identifier — unii candidate
2 equally ranked IID candidates
SORBITAN SESQUIOLEATESORBITAN SESQUIOLEATE0W8RRI5W5AOINTMENT / TOPICAL75 mgExact identifier — unii candidate
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION, CONCENTRATE / ORAL200 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGRANULE, EFFERVESCENT / ORAL60 mgExact identifier — unii candidate
35 equally ranked IID candidates
ALUMINUM STEARATEALUMINUM STEARATEU6XF9NP8HMCREAM / TOPICAL0.01 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / TRANSDERMAL306.2 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUPOWDER, FOR SUSPENSION / ORAL160 mgExact identifier — unii candidate
35 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, COATED / ORAL1 mgExact identifier — unii candidate
75 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
9 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / SUBLINGUAL17.5 mgExact identifier — unii candidate
39 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, CHEWABLE / ORAL12 mgExact identifier — unii candidate
75 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, EXTENDED RELEASE / ORAL0.01 mgExact identifier — unii candidate
9 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii candidate
75 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii candidate
39 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET, COATED / ORAL0.2 mgExact identifier — unii candidate
35 equally ranked IID candidates
BUTYLENE GLYCOLBUTYLENE GLYCOL3XUS85K0RASYSTEM / TRANSDERMAL8.12 mgExact identifier — unii candidate
2 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)R33S7TK2EPSOLUTION / TOPICAL0.6 %w/vExact identifier — unii candidate
YELLOW WAXYELLOW WAX2ZA36H0S2VCREAM / TOPICAL5 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRAVENOUS33750 mgExact identifier — unii candidate
75 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30LOZENGE / TRANSMUCOSAL100 mgExact identifier — unii candidate
39 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS225 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUELIXIR / ORAL5.02 mg/5mlExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUINJECTION, SOLUTION / INTRAMUSCULAR4.8 %w/vExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUINJECTION / INTRAMUSCULAR864 mgExact identifier — unii candidate
35 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
3 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSUSPENSION / ORAL320 mgExact identifier — unii candidate
35 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXJELLY / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / SUBCUTANEOUS450 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / ORAL42 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY / NASAL22.3 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
ALUMINUM STEARATEALUMINUM STEARATEU6XF9NP8HMTABLET, EXTENDED RELEASE / ORAL105 mgExact identifier — unii candidate
5 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED, EXTENDED RELEASE / ORAL53 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CAPSULE, EXTENDED RELEASE / ORAL117 mgExact identifier — unii candidate
39 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / ORAL750 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / OPHTHALMIC12 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGRANULE, FOR SUSPENSION / ORAL120 mgExact identifier — unii candidate
35 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET / ORAL3.22 mgExact identifier — unii candidate
9 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CAPSULE / ORAL256.4 mgExact identifier — unii candidate
39 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
35 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / AURICULAR (OTIC)25 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLUCONOLACTONEGLUCONOLACTONEWQ29KQ9POTINJECTION / INTRAVENOUSADJ PHExact identifier — unii candidate
6 equally ranked IID candidates

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
9925d60e-c434-4419-9304-953455e8dd6f253c4065-bb58-413f-8ee4-dbd1576f33ae2024-12-18WarningsExact identifier
spl id: 9925d60e-c434-4419-9304-953455e8dd6f
spl set id: 253c4065-bb58-413f-8ee4-dbd1576f33ae

Reported adverse events (FAERS/openFDA)#

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