Earths Care Eczema: Package Insert and Label Information

EARTHS CARE ECZEMA- oatmeal lotion
DLC Laboratories, Inc.

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.

Drug Facts

Active ingredient

Colloidal oatmeal 2%

Purpose

Skin Protectant

Uses

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

  • eczema
  • rashes

Warnings

  • For external use only

When using this product

  • avoid contact with eyes

Stop use and ask a doctor if

  • condition worsens
  • symptoms persist for 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 a Poison Control Center immediately.

Directions

  • apply to affected areas of skin as needed

Inactive ingredients

Aloe barbadensis (aloe vera) extract, alpha-bisabolol, Argania spinosa (argan) kernel oil, benzyl alcohol, Butyrospermum parkii (shea) butter, caprylic/capric triglyceride, cetyl hydroxyethylcellulose, citric acid, ethylhexylglycerin, glycerin, heptyl undecylenate, Persea gratissima (avocado) oil, phenoxyethanol, polyglyceryl-3 dicitrate/stearate, potassium sorbate, Prunus amygdalus dulcis (sweet almond) oil, purified water, Simmondsia chinensis (jojoba) oil, tetrasodium EDTA, tocopherols, Zingiber officinale (ginger) root extract.

Questions

1-888-602-6380

Distributed by:
Earth’s Care Natural Products, Inc.
Long Beach, California 90805 USA

PRINCIPAL DISPLAY PANEL — 237 mL Bottle Label

Steroid-Free-Allergy Tested

EARTH’S
CARE ®

• PARABEN
FREE •

Eczema
Lotion

2% Colloidal Oatmeal

Skin Protectant


Soothes and Relieves Itching


Due to Eczema & Rashes

with Aloe and Almond Oil

1%
FOR THE
PLANET SM
MEMBER

8 FL OZ (237 mL)

PRINCIPAL DISPLAY PANEL -- 237 mL Bottle Label
(click image for full-size original)
EARTHS CARE ECZEMA
oatmeal lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:24286-1571
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OATMEAL (OATMEAL) OATMEAL 1.8 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
GINGER OIL
ALOE VERA LEAF
CETYL HYDROXYETHYLCELLULOSE (350000 MW)
EDETATE SODIUM
GLYCERIN
SHEA BUTTER
ALMOND OIL
MEDIUM-CHAIN TRIGLYCERIDES
HEPTYL UNDECYLENATE
JOJOBA OIL
AVOCADO OIL
.ALPHA.-BISABOLOL, (+/-)-
ARGAN OIL
TOCOPHEROL
POTASSIUM SORBATE
PHENOXYETHANOL
ETHYLHEXYLGLYCERIN
BENZYL ALCOHOL
ANHYDROUS CITRIC ACID
Product Characteristics
Color white (Off-white) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:24286-1571-8 237 mL in 1 BOTTLE, PUMP None
2 NDC:24286-1571-1 2.9 mL in 1 POUCH None
3 NDC:24286-1571-2 12.4 mL in 1 JAR None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 11/19/2018
Labeler — DLC Laboratories, Inc. (093351930)
Establishment
Name Address ID/FEI Operations
DLC Laboratories, Inc. 093351930 manufacture (24286-1571), label (24286-1571)

Revised: 11/2022 DLC Laboratories, Inc.

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