ECZEMA CARE SKIN PROTECTANT- oatmeal lotion

eczema care skin protectant by

Drug Labeling and Warnings

eczema care skin protectant by is a Otc medication manufactured, distributed, or labeled by KAS Direct LLC dba BabyGanics. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Colloidal oatmeal 1%

Purpose

Skin protectant

Uses

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

• rashes
• eczema

Warnings

For external use only

When using this product do not get into eyes

Stop use and ask a doctor if

• condition worsens
• symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

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

Other information

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

Inactive ingredients

water, butyrospermum parkii (shea) butter1, cetearyl alcohol, cetyl alcohol, isopropyl palmitate, glycerin1, glyceryl stearate, theobroma cacao (cocoa) seed butter1, hydrolyzed oats, solanum lycopersicum (tomato) seed oil, helianthus annuus (sunflower) seed oil1, vaccinium macrocarpon (cranberry) seed oil, nigella sativa (black cumin) seed oil1, rubus idaeus (red raspberry) seed oil, cetearyl glucoside, tocopherol, glyceryl dilaurate, caprylyl glycol, xanthan gum, sodium hydroxide, sodium phytate, triethyl citrate, ethylhexylglycerin, benzoic acid.

1 Certified Organic Ingredient
Unless otherwise specified, product not labeled as organic

SPL UNCLASSIFIED SECTION

dist. by KAS direct, LLC
Westbury, NY 11590

PRINCIPAL DISPLAY PANEL - 226 g Tube Label

ACCEPTED
NATIONALECZEMA.ORG
NATIONAL
ECZEMA
ASSOCIATION

babyganics

eczema care skin
protectant cream

fragrance free

relieves dry, itchy,
irritated skin
non-allergenic ∙
pediatrician &
dermatologist tested

formulated with:
colloidal oatmeal*

formulated without:
cortisone, steroids,
parabens, phthalates
or fragrances

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

Net wt 8 OZ (226 g)

INGREDIENTS AND APPEARANCE

ECZEMA CARE SKIN PROTECTANT 
oatmeal lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59062-1305
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SHEA BUTTER (UNII: K49155WL9Y)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL ALCOHOL (UNII: 936JST6JCN)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
COCOA BUTTER (UNII: 512OYT1CRR)
OAT (UNII: Z6J799EAJK)
NIGELLA SATIVA SEED OIL (UNII: CS4U38E731)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
BENZOIC ACID (UNII: 8SKN0B0MIM)
RASPBERRY SEED OIL (UNII: 9S8867952A)
CRANBERRY SEED OIL (UNII: 73KDS3BW5E)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
TOCOPHEROL (UNII: R0ZB2556P8)
GLYCERYL DILAURATE (UNII: MFL3ZIE8SK)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
XANTHAN GUM (UNII: TTV12P4NEE)
PHYTATE SODIUM (UNII: 88496G1ERL)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
TOMATO (UNII: Z4KHF2C175)
SUNFLOWER OIL (UNII: 3W1JG795YI)
SOYBEAN OIL (UNII: 241ATL177A)
Sodium Hydroxide (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59062-1305-8	226 g in 1 TUBE; Type 0: Not a Combination Product	04/08/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	04/08/2019

Labeler - KAS Direct LLC dba BabyGanics (002764605)