ECZEMA- oatmeal lotion/shampoo 
ORGANIC & SUSTAINABLE BEAUTY

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

ECZEMA SHAMPOO & BODYWASH

Drug Facts

Active ingredient

Colloidal Oatmeal 1%

Purpose

Skin Protectant

Uses

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

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

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.

Principal Display Panel - 562 mL Bottle Label
ECZEMA 
oatmeal lotion/shampoo
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52915-010
Route of Administration TOPICAL DEA Schedule     
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)

Revised: 9/2013
Document Id: 9e852356-81c0-4373-b9f3-845a444c7a22
Set id: 81eb3df4-5beb-45aa-82ca-e8b4b37e45f4
Version: 1
Effective Time: 20130909
 
ORGANIC & SUSTAINABLE BEAUTY