babyganics® Eczema Lotion

Manufacturer: KAS Direct LLC dba BabyGanics
Effective date: 2024-12-19
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: legacy-cache
Hydrated at: 2026-08-01 20:44:48

Label at a glance#

ProductBABYGANICS ECZEMA

Active ingredientOATMEAL

Label structure10 sections

Indications and uses

temporarily protects and helps relieve minor skin irritation and itching due to: rashes eczema

Dosage and administration

apply as needed massage into baby's skin, especially after bathing - perfect for face and body for use on mild to moderate eczema or as directed by a physician

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

Colloidal oatmeal 1%

Purpose

OTC - PURPOSE SECTION

Skin protectant

Uses

INDICATIONS & USAGE SECTION

temporarily protects and helps relieve minor skin irritation and itching due to:

rashes
eczema

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

apply as needed
massage into baby's skin, especially after bathing - perfect for face and body
for use on mild to moderate eczema or as directed by a physician

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, cetearyl alcohol, cetyl alcohol, isopropyl palmitate, glycerin, glyceryl stearate, theobroma cacao (cocoa) seed butter, hydrolyzed oats, 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, cetearyl glucoside, tocopherol, glyceryl dilaurate, caprylyl glycol, xanthan gum, sodium phytate, ethylhexylglycerin, citric acid, sodium hydroxymethylglycinate

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 85 g Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

extra
soothing

babyganics_®

eczema care
skin protectant cream

with colloidal oatmeal ∙ relieves dry,
itchy, irritated skin ∙ non–allergenic
pediatrician & dermatologist tested

no: cortisone, steroids, parabens,
sulfates, phthalates or fragrances

+ NeoNourish* Natural Seed Oil Blend

3 OZ (85g)

Principal Display Panel - 85 g Tube Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
59062-1303-1	2020-02-04	C162847	48780-1	9d75b9d1-1875-f424-e053-dadaa90a57ce	babyganics® Eczema Lotion
59062-1303-1	2020-01-31	C162847	48780-1	9d75b9d1-1875-f424-e053-dadaa90a57ce	babyganics® Eczema Lotion

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59062-1303	BABYGANICS ECZEMA (OATMEAL) LOTION [KAS DIRECT LLC DBA BABYGANICS]	5	Legacy NDC	20241222_8dc620b9-6d75-46a3-9a8d-d796d5027b0f.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
OATMEAL	ACTIVE INGREDIENT	8PI54V663Y	2
OATMEAL	ACTIVE MOIETY	8PI54V663Y	2
CAPRYLYL GLYCOL	INACTIVE INGREDIENT	00YIU5438U	2
CARROT SEED OIL	INACTIVE INGREDIENT	595AO13F11	2
CETEARYL GLUCOSIDE	INACTIVE INGREDIENT	09FUA47KNA	2
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	2
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	2
CHIA SEED OIL	INACTIVE INGREDIENT	MC2LH51BO7	2
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	2
COCOA BUTTER	INACTIVE INGREDIENT	512OYT1CRR	2
CRANBERRY SEED OIL	INACTIVE INGREDIENT	73KDS3BW5E	2
ETHYLHEXYLGLYCERIN	INACTIVE INGREDIENT	147D247K3P	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	2
GLYCERYL DILAURATE	INACTIVE INGREDIENT	MFL3ZIE8SK	2
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	2
ISOPROPYL PALMITATE	INACTIVE INGREDIENT	8CRQ2TH63M	2
NIGELLA SATIVA SEED OIL	INACTIVE INGREDIENT	CS4U38E731	2
OAT	INACTIVE INGREDIENT	Z6J799EAJK	2
PHYTATE SODIUM	INACTIVE INGREDIENT	88496G1ERL	2
RASPBERRY SEED OIL	INACTIVE INGREDIENT	9S8867952A	2
SHEA BUTTER	INACTIVE INGREDIENT	K49155WL9Y	2
SODIUM HYDROXYMETHYLGLYCINATE	INACTIVE INGREDIENT	DIG6BWZ9XT	2
TOCOPHEROL	INACTIVE INGREDIENT	R0ZB2556P8	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	2
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	2

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

BABYGANICS ECZEMA
OATMEAL
WATER
SHEA BUTTER
CETOSTEARYL ALCOHOL
CETYL ALCOHOL
ISOPROPYL PALMITATE
GLYCERIN
GLYCERYL MONOSTEARATE
COCOA BUTTER
OAT
NIGELLA SATIVA SEED OIL
CARROT SEED OIL
CHIA SEED OIL
RASPBERRY SEED OIL
CRANBERRY SEED OIL
CETEARYL GLUCOSIDE
TOCOPHEROL
GLYCERYL DILAURATE
CAPRYLYL GLYCOL
XANTHAN GUM
PHYTATE SODIUM
ETHYLHEXYLGLYCERIN
CITRIC ACID MONOHYDRATE
SODIUM HYDROXYMETHYLGLYCINATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
59062-1303	59062-1303-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
OATMEAL	8PI54V663Y	ACTIB
WATER	059QF0KO0R	IACT
SHEA BUTTER	K49155WL9Y	IACT
CETOSTEARYL ALCOHOL	2DMT128M1S	IACT
CETYL ALCOHOL	936JST6JCN	IACT
ISOPROPYL PALMITATE	8CRQ2TH63M	IACT
GLYCERIN	PDC6A3C0OX	IACT
GLYCERYL MONOSTEARATE	230OU9XXE4	IACT
COCOA BUTTER	512OYT1CRR	IACT
OAT	Z6J799EAJK	IACT
NIGELLA SATIVA SEED OIL	CS4U38E731	IACT
CARROT SEED OIL	595AO13F11	IACT
CHIA SEED OIL	MC2LH51BO7	IACT
RASPBERRY SEED OIL	9S8867952A	IACT
CRANBERRY SEED OIL	73KDS3BW5E	IACT
CETEARYL GLUCOSIDE	09FUA47KNA	IACT
TOCOPHEROL	R0ZB2556P8	IACT
GLYCERYL DILAURATE	MFL3ZIE8SK	IACT
CAPRYLYL GLYCOL	00YIU5438U	IACT
XANTHAN GUM	TTV12P4NEE	IACT
PHYTATE SODIUM	88496G1ERL	IACT
ETHYLHEXYLGLYCERIN	147D247K3P	IACT
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
SODIUM HYDROXYMETHYLGLYCINATE	DIG6BWZ9XT	IACT

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 5 · 257 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	GEL / TOPICAL		1 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, CHEWABLE / ORAL	7 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	AEROSOL, FOAM / RECTAL		7 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	GEL / TOPICAL		58 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION / OPHTHALMIC		2 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	SUPPOSITORY / RECTAL	35 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	CAPSULE, DELAYED RELEASE / ORAL		15 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	CREAM / VAGINAL		200 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GUM, CHEWING / BUCCAL		230 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / SOFT TISSUE	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / EPIDURAL	0.02 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	LOTION / TOPICAL	0.3 %w/v		Exact identifier — unii candidate 29 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRAVENOUS	2068 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	POWDER, FOR SOLUTION / TOPICAL	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / RESPIRATORY (INHALATION)	5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, EFFERVESCENT / ORAL	460 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SUSPENSION / OPHTHALMIC	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET / ORAL	33.34 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SYSTEM / IONTOPHORESIS	0.2 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SOLUTION / INTRAVENOUS		396 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	ELIXIR / ORAL		5621 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	LIQUID / TOPICAL	2.5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
ISOPROPYL PALMITATE	ISOPROPYL PALMITATE	8CRQ2TH63M	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 8 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SUSPENSION, EXTENDED RELEASE / ORAL	140.8 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION/ DROPS / OPHTHALMIC	2.5 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	LIQUID / TOPICAL	1 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	PASTE / ORAL		1050 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / AURICULAR (OTIC)	0.2 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / INTRAVENOUS	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / OPHTHALMIC	6 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SOLUTION / INTRA-ARTICULAR	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	TABLET, COATED / ORAL	0.25 mg		Exact identifier — unii candidate 20 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	EMULSION / TOPICAL	0.11 %w/w		Exact identifier — unii candidate 88 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET, CHEWABLE / ORAL		1 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, COATED / ORAL	1 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	CREAM / VAGINAL	0.49 %w/w		Exact identifier — unii candidate 88 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	DROPS / NASAL	10 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	CREAM / TOPICAL		4 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SYSTEM / TOPICAL	0.2 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION, CONCENTRATE / INTRAVENOUS	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET / PERIODONTAL	0.53 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SYSTEM / IONTOPHORESIS	168.1 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	POWDER, FOR SOLUTION / ORAL	10 mg/5ml		Exact identifier — unii candidate 29 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, COATED / ORAL	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION/ DROPS / ORAL		22 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SPRAY, METERED / NASAL		2 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	DOUCHE / VAGINAL	1 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION/ DROPS / AURICULAR (OTIC)		25 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	POWDER / ORAL		840 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	SPRAY / TOPICAL	1 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		23 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL		2350 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	LIQUID / INTRAVENOUS	0.2 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	LIQUID / RESPIRATORY (INHALATION)	0.13 %w/w		Exact identifier — unii candidate 88 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CONCENTRATE / ORAL		1800 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SOLUTION, CONCENTRATE / IRRIGATION		1 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	EMULSION / ORAL	NA		Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION / SUBCUTANEOUS		450 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION / ORAL		26208 mg	Exact identifier — unii candidate 75 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
4a139380-0ae4-4904-8afb-e9715755a237			8dc620b9-6d75-46a3-9a8d-d796d5027b0f	2024-12-19	Warnings	Exact identifier spl id: 4a139380-0ae4-4904-8afb-e9715755a237 spl set id: 8dc620b9-6d75-46a3-9a8d-d796d5027b0f

Reported adverse events (FAERS/openFDA)#

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