ECZEMA by ORGANIC & SUSTAINABLE BEAUTY ECZEMA- oatmeal cream

ECZEMA by

Drug Labeling and Warnings

ECZEMA by is a Otc medication manufactured, distributed, or labeled by ORGANIC & SUSTAINABLE BEAUTY. 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
• poison ivy, oak, or sumac
• insect bites

Warnings

External use only.

When using this product

• patch test before use
• keep out of eyes
• clean with soap and water to remove

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 Poison Control within the U.S. (1-800-222-1222)

Directions

• apply liberally onto desired area
• reapply as needed.

Children under 6 months: ask a doctor. Use in combination with our Eczema Shampoo & Bodywash.

Other information

You may report a serious adverse reaction event from using this product to: 5933 Bowcroft St. Los Angeles, CA 90016

Inactive ingredients

Water, caprylic/capric triglyceride, cetyl alcohol, stearic acid, cetearyl olivate and sorbitan olivate, canola oil, allantoin, calendula officinalis flower extract, viola tricolor extract, yucca schidigera root extract, aloe barbadensis leaf juice, rosmarinus officinalis leaf extract, pure essential oils of lavandula angustifolia oil and salvia sclarea oil, phytic acid, caprylhydroxamic acid, glyceryl caprylate.

PRINCIPAL DISPLAY PANEL - 133 mL Container Label

CALIF♥RNIA BABY®
trusted since 1995

NEW &
IMPROVED!

therapeutic relief
COLLOIDAL OATMEAL (CONTAINS GLUTEN)

ECZEMA
CREAM

SKIN PROTECTANT RELIEVES SKIN DUE TO ECZEMA
OR RASHES HELPS HEAL & PROTECT DELICATE SKIN
ULTRA MOISTURIZING STEROID-FREE

CALENDULA & LAVENDER
FACE & BODY

ALLERGY
TESTED

for babies kids
sensitive adults

133 mL / 4.5 Fl. Oz.

INGREDIENTS AND APPEARANCE

ECZEMA 
oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52915-120
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 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
medium-chain triglycerides (UNII: C9H2L21V7U)
cetyl alcohol (UNII: 936JST6JCN)
stearic acid (UNII: 4ELV7Z65AP)
cetearyl olivate (UNII: 58B69Q84JO)
sorbitan olivate (UNII: MDL271E3GR)
canola oil (UNII: 331KBJ17RK)
allantoin (UNII: 344S277G0Z)
calendula officinalis flower (UNII: P0M7O4Y7YD)
viola tricolor (UNII: 9Q24RAI43V)
yucca schidigera root (UNII: E2H9ET15AT)
aloe vera leaf (UNII: ZY81Z83H0X)
rosemary (UNII: IJ67X351P9)
lavender oil (UNII: ZBP1YXW0H8)
clary sage oil (UNII: 87L0D4U3M0)
fytic acid (UNII: 7IGF0S7R8I)
caprylhydroxamic acid (UNII: UPY805K99W)
glyceryl caprylate (UNII: TM2TZD4G4A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52915-120-45	133 mL in 1 CONTAINER
2	NDC: 52915-120-05	14 mL in 1 TUBE
3	NDC: 52915-120-19	562 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	12/01/2012

Labeler - ORGANIC & SUSTAINABLE BEAUTY (020085717)