ECZEMA- oatmeal lotion/shampoo

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
• to avoid slipping, use mat in tub or shower

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

• dispense a dime-to-quarter sized amount into palm, massage into wet hair starting at the scalp and working to the ends. Rinse.
• for extra cleansing, allow to sit for 30 seconds and then rinse.

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, decyl glucoside, lauryl glucoside, quillaja saponaria bark extract, glycerine, allantoin, calendula officinalis flower extract, viola tricolor extract, yucca schidigera root extract, aloe barbadensis leaf juice, simmondsia chinensis (jojoba) seed oil, hydrolyzed quinoa, xanthan gum, panthenol, phytic acid, gluconolactone, sodium benzoate.

PRINCIPAL DISPLAY PANEL - 562 mL Bottle Label

CALIF♥RNIA BABY®
safe ♥ natural ♥ fun

NEW &
IMPROVED!

therapeutic relief

COLLOIDAL OATMEAL (CONTAINS GLUTEN)

ECZEMA
SHAMPOO & BODYWASH

SKIN PROTECTANT GENTLY CLEANSES SENSITIVE OR IRRITATED SKIN
DUE TO ECZEMA HELPS HEAL & PROTECT DELICATE SKIN
NO SULFATES, STEROIDS OR ALCOHOL

NO ADDED FRAGRANCE
HAIR, FACE & BODY

ALLERGY
TESTED

for babies kids
sensitive adults

562 mL / 19 Fl. Oz.

INGREDIENTS AND APPEARANCE

ECZEMA 
oatmeal lotion/shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52915-010
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)
decyl glucoside (UNII: Z17H97EA6Y)
lauryl glucoside (UNII: 76LN7P7UCU)
quillaja saponaria bark (UNII: 8N0K3807ZW)
glycerin (UNII: PDC6A3C0OX)
allantoin (UNII: 344S277G0Z)
calendula officinalis flower (UNII: P0M7O4Y7YD)
viola tricolor (UNII: 9Q24RAI43V)
yucca schidigera root (UNII: E2H9ET15AT)
aloe vera leaf (UNII: ZY81Z83H0X)
jojoba oil (UNII: 724GKU717M)
quinoa oil (UNII: M437LS0K52)
xanthan gum (UNII: TTV12P4NEE)
panthenol (UNII: WV9CM0O67Z)
fytic acid (UNII: 7IGF0S7R8I)
gluconolactone (UNII: WQ29KQ9POT)
sodium benzoate (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52915-010-19	562 mL in 1 BOTTLE, PUMP
2	NDC: 52915-010-05	14 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	10/01/2012

Labeler - ORGANIC & SUSTAINABLE BEAUTY (020085717)