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.

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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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:52915-010
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OATMEAL (OATMEAL) OATMEAL10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water 
decyl glucoside 
lauryl glucoside 
quillaja saponaria bark 
glycerin 
allantoin 
calendula officinalis flower 
viola tricolor 
yucca schidigera root 
aloe vera leaf 
jojoba oil 
quinoa oil 
xanthan gum 
panthenol 
fytic acid 
gluconolactone 
sodium benzoate 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52915-010-19562 mL in 1 BOTTLE, PUMP
2NDC:52915-010-0514 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34710/01/2012
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