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NDC 70381-0123-02 Quick Relief Colloidal Oatmeal Treatment 5 g/100mL Details

Quick Relief Colloidal Oatmeal Treatment 5 g/100mL

Quick Relief Colloidal Oatmeal Treatment is a TOPICAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Murad, LLC. The primary component is OATMEAL.

Product Information

NDC	70381-0123
Product ID	70381-123_0ed57877-ede8-47d1-a342-0d91a2ce63f4
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	Quick Relief Colloidal Oatmeal Treatment
Proprietary Name Suffix	for face, eyes and body
Non-Proprietary Name	Colloidal Oatmeal
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	TOPICAL
Active Ingredient Strength	5
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 70381-0123-02 (70381012302)

Pricing Information	N/A
NDC Package Code	70381-123-02
Billing NDC	70381012302
Package	1 TUBE in 1 CARTON (70381-123-02) / 50 mL in 1 TUBE (70381-123-01)
Marketing Start Date	2022-11-02
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL f2c9d0b3-52ed-48b6-afbe-1d06b4b01c04 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Colloidal Oatmeal 5.0 %

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), Squalane, Propanediol, Cetearyl Olivate, Sorbitan Olivate, Coco-Caprylate/Caprate, Musa Sapientum (Banana) Leaf/Trunk Extract, Cetyl Alcohol, Avena Sativa (Oat) Kernel Extract, Betaine, Butyrospermum Parkii (Shea) Butter, Polyglyceryl-10 Myristate, Hydrogenated Lecithin, Physalis Pubescens Fruit Juice, Albatrellus Confluens (Mushroom) Extract, Niacinamide, Allantoin, Tocopherol, Jojoba Esters, Ethylhexylglycerin, Caprylic/Capric Triglyceride, Hectorite, Carbomer, Caprylhydroxamic Acid, Tetrasodium Glutamate Diacetate, Sodium Hydroxide, Citric Acid, Chlorphenesin

Questions or comments?

1.800.33.MURAD or Murad.com

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton

ECZEMA

CONTROL

+

Murad®

Quick Relief

Colloidal

Oatmeal

Treatment

for face, eyes

and body

5.0% colloidal oatmeal

skin protectant

℮ 50 mL NET VOL 1.7 FL OZ

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton

INGREDIENTS AND APPEARANCE

QUICK RELIEF COLLOIDAL OATMEAL TREATMENT FOR FACE, EYES AND BODY

colloidal oatmeal solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70381-123
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	5 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SQUALANE (UNII: GW89575KF9)
PROPANEDIOL (UNII: 5965N8W85T)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
SORBITAN OLIVATE (UNII: MDL271E3GR)
COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)
CETYL ALCOHOL (UNII: 936JST6JCN)
OAT (UNII: Z6J799EAJK)
BETAINE (UNII: 3SCV180C9W)
SHEA BUTTER (UNII: K49155WL9Y)
POLYGLYCERYL-10 MYRISTATE (UNII: Y9WL8QN3ZB)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
PHYSALIS PUBESCENS FRUIT JUICE (UNII: GM2TDN9DZI)
ALBATRELLUS CONFLUENS FRUITING BODY (UNII: 7UVG8A4DP0)
NIACINAMIDE (UNII: 25X51I8RD4)
ALLANTOIN (UNII: 344S277G0Z)
TOCOPHEROL (UNII: R0ZB2556P8)
HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HECTORITE (UNII: 08X4KI73EZ)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CHLORPHENESIN (UNII: I670DAL4SZ)
MUSA X PARADISIACA LEAF (UNII: 2UIJ27N6ED)

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:70381-123-02	1 in 1 CARTON	11/02/2022
1	NDC:70381-123-01	50 mL in 1 TUBE; 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(70381-123)

Revised: 6/2022

Document Id: 0ed57877-ede8-47d1-a342-0d91a2ce63f4

Set id: f2c9d0b3-52ed-48b6-afbe-1d06b4b01c04

Version: 2

Effective Time: 20220617