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NDC 70381-0122-02 Daily Defense Colloidal Oatmeal 1 g/100mL Details

Daily Defense Colloidal Oatmeal 1 g/100mL

Daily Defense Colloidal Oatmeal is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Murad, LLC. The primary component is OATMEAL.

Product Information

NDC	70381-0122
Product ID	70381-122_e0785af0-ecda-4f08-b81f-be90a52a8062
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Daily Defense Colloidal Oatmeal
Proprietary Name Suffix	for face and eyes
Non-Proprietary Name	Colloidal Oatmeal
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	1
Active Ingredient Units	g/100mL
Substance Name	OATMEAL
Labeler Name	Murad, LLC
Pharmaceutical Class	Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part347
Listing Certified Through	2023-12-31

Package

Package Images

NDC 70381-0122-02 (70381012202)

Pricing Information	N/A
NDC Package Code	70381-122-02
Billing NDC	70381012202
Package	1 BOTTLE in 1 CARTON (70381-122-02) / 50 mL in 1 BOTTLE (70381-122-01)
Marketing Start Date	2022-11-02
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d3636217-0a65-491c-8883-0f1abadf8f68 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Colloidal Oatmeal 1.0%

Purpose

Skin Protectant

Use

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

eczema
rashes

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 a Poison Control Center right away.

Directions

Apply as needed.

Inactive ingredients

Water (Aqua), Glycerin, Butyrospermum Parkii (Shea) Butter, Propanediol, Caprylic/Capric Triglyceride, Glyceryl Stearate, Avena Sativa (Oat) Kernel Extract, Betaine, Ophiopogon Japonicus Root Extract, Niacinamide, Hydrogenated Lecithin, Ethylhexylglycerin, Maltodextrin, Cetearyl Alcohol, Cetearyl Glucoside, Lauryl Laurate, Cetyl Myristate, Sodium Polyacrylate Starch, Carbomer, Hectorite, Caprylhydroxamic Acid, Tetrasodium Glutamate Diacetate, Sodium Hydroxide, Chlorphenesin

Questions or comments?

1.800.33.MURAD or Murad.com

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

ECZEMA CONTROL

+

Murad®

Daily Defense

Colloidal Oatmeal Cream

for face and eyes

1.0% colloidal oatmeal

skin protectant

℮ 50 mL NET VOL 1.7 FL OZ

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

INGREDIENTS AND APPEARANCE

DAILY DEFENSE COLLOIDAL OATMEAL FOR FACE AND EYES

colloidal oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70381-122
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	1 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SHEA BUTTER (UNII: K49155WL9Y)
PROPANEDIOL (UNII: 5965N8W85T)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
OAT (UNII: Z6J799EAJK)
BETAINE (UNII: 3SCV180C9W)
OPHIOPOGON JAPONICUS ROOT (UNII: 90PS6JV9GZ)
NIACINAMIDE (UNII: 25X51I8RD4)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
LAURYL LAURATE (UNII: GPW77G0937)
CETYL MYRISTATE (UNII: 7OPL833Q4D)
HECTORITE (UNII: 08X4KI73EZ)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CHLORPHENESIN (UNII: I670DAL4SZ)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
SODIUM POLYACRYLATE STARCH (25 MICROMETER PARTICLE) (UNII: KXY4EH7RJV)

Product Characteristics
Color	WHITE (Light Beige to Beige)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70381-122-02	1 in 1 CARTON	11/02/2022
1	NDC:70381-122-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part347	11/02/2022

Labeler - Murad, LLC (781254792)

Name	Address	ID/FEI	Business Operations
Establishment
KDC/One Chatsworth, Inc.		118542196	MANUFACTURE(70381-122)

Revised: 6/2022

Document Id: e0785af0-ecda-4f08-b81f-be90a52a8062

Set id: d3636217-0a65-491c-8883-0f1abadf8f68

Version: 5

Effective Time: 20220615