ECZEMA- oatmeal cream 
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 CREAM

Drug Facts

Active ingredient

Colloidal Oatmeal 1%

Purpose

Skin Protectant

Uses

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

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

Directions

Apply liberally onto desired area

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, calendula officinalis flower extract, caprylic/capric triglyceride, cetyl alcohol, stearic acid, cetearyl olivate, sorbitan olivate, canola oil, allantoin, viola tricolor extract, yucca schidigera root extract, aloe barbadensis leaf juice, rosmarinus officinalis leaf extract, lavandula angustifolia (lavender) oil, salvia sclarea (clary) oil, phytic acid, caprylhydroxamic acid, glyceryl caprylate.

PRINCIPAL DISPLAY PANEL - 133 mL Container Label

CALIF♥RNIA BABY®
TRUSTED SINCE 1995

therapeutic relief™

GLUTEN-FREE!
ECZEMA
CREAM
SKIN PROTECTANT

OATMEAL & CALENDULA
HELPS HEAL & PROTECT DELICATE SKIN
FOR BABIES, KIDS & SENSITIVE ADULTS

ALLERGY
TESTED

133 mL/4.5 fl. oz.

PRINCIPAL DISPLAY PANEL - 133 mL Container Label
ECZEMA 
oatmeal cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52915-120
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 WHOLE (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 MONOCAPRYLATE (UNII: TM2TZD4G4A)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52915-120-45133 mL in 1 CONTAINER; Type 0: Not a Combination Product12/01/2012
2NDC:52915-120-0514 mL in 1 TUBE; Type 0: Not a Combination Product12/01/2012
3NDC:52915-120-0257 mL in 1 JAR; Type 0: Not a Combination Product12/01/2012
4NDC:52915-120-19562 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product12/01/201207/31/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34712/01/2012
Labeler - ORGANIC & SUSTAINABLE BEAUTY (020085717)

Revised: 11/2020
Document Id: 0d86dbed-a022-4bba-979e-54b15d3fe4bd
Set id: 926706b5-0a08-4604-b5ad-3b3ddfd7f02d
Version: 2
Effective Time: 20201109
 
ORGANIC & SUSTAINABLE BEAUTY