Eczema (Oatmeal) Lotion/shampoo [Organic & Sustainable Beauty] -

ECZEMA (OATMEAL) LOTION/SHAMPOO [ORGANIC & SUSTAINABLE BEAUTY]
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NDC	52915-010-05, 52915-010-19
Set ID	81eb3df4-5beb-45aa-82ca-e8b4b37e45f4
Category	HUMAN OTC DRUG LABEL
Packager	ORGANIC & SUSTAINABLE BEAUTY
Generic Name
Product Class
Product Number
Application Number	PART347

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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®

TRUSTED
SINCE 1995

eczema therapy

SHAMPOO &
BODYWASH
SKIN PROTECTANT

GLUTEN FREE + STEROID FREE

GENTLE • NON-DRYING • NO ADDED FRAGRANCE

BABIES + KIDS + ADULTS

ALLERGY
TESTED

© 2019

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	10 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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 WHOLE (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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:52915-010-19	562 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	10/01/2012
2	NDC:52915-010-05	14 mL in 1 TUBE; Type 0: Not a Combination Product	10/01/2012
3	NDC:52915-010-85	251 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/01/2012

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

Labeler - ORGANIC & SUSTAINABLE BEAUTY (020085717)

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Medic

ECZEMA (OATMEAL) LOTION/SHAMPOO [ORGANIC & SUSTAINABLE BEAUTY]

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