AVEENO ECZEMA THERAPY NIGHTTIME ITCH RELIEF BALM- colloidal oatmeal cream

Aveeno Eczema Therapy Nighttime Itch Relief Balm by

Drug Labeling and Warnings

Aveeno Eczema Therapy Nighttime Itch Relief Balm by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

Other Information

• protect from excessive heat (40°C/104°F)

Inactive Ingredients

Glycerin, Water, Cetearyl Alcohol, Hexyldecanol, Dimethicone, Cetyl Alcohol, Avena Sativa (Oat) Kernel Oil, Avena Sativa (Oat) Kernel Extract, Benzyl Alcohol, Ethylhexylglycerin, Sodium Cetearyl Sulfate, Benzoic Acid, Stearic Acid, Dipotassium Phosphate, Potassium Phosphate, p-Anisic Acid, Caprylic/Capric Triglyceride, Ceramide NP, Sodium Hydroxide, Citric Acid

Questions?

866-428-3366; Outside US, dial collect 215-273-8755

www.aveeno.com

SPL UNCLASSIFIED SECTION

Distributed by:

Kenvue Brands LLC
Summit, NJ 07901

PRINCIPAL DISPLAY PANEL - 312 g Jar

NEW LOOK

Aveeno ®

Eczema Therapy

Nighttime Itch Relief Balm

1% Colloidal Oatmeal Skin Protectant

Eczema-Prone | Sensitive Skin

Itch relief that starts working instantly

with intense, long-lasting moisture

Colloidal Oatmeal + Ceramide

Steroid Free Fragrance Free

ACCEPTED

e

National

Eczema

Association

DERMATOLOGIST RECOMMENDED BRAND

LEADER IN OAT SCIENCE

Net wt. 11 oz. (312 g)

INGREDIENTS AND APPEARANCE

AVEENO ECZEMA THERAPY NIGHTTIME ITCH RELIEF BALM 
colloidal oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0772
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
HEXYLDECANOL (UNII: 151Z7P1317)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)
BENZOIC ACID (UNII: 8SKN0B0MIM)
DIBASIC POTASSIUM PHOSPHATE (UNII: CI71S98N1Z)
POTASSIUM PHOSPHATE, UNSPECIFIED FORM (UNII: B7862WZ632)
P-ANISIC ACID (UNII: 4SB6Y7DMM3)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETYL ALCOHOL (UNII: 936JST6JCN)
STEARIC ACID (UNII: 4ELV7Z65AP)
OAT (UNII: Z6J799EAJK)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CERAMIDE NP (UNII: 4370DF050B)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
OAT KERNEL OIL (UNII: 3UVP41R77R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0772-2	12 in 1 PACKET	08/01/2022
1		28 g in 1 JAR; Type 0: Not a Combination Product
2	NDC: 69968-0772-1	312 g in 1 JAR; Type 0: Not a Combination Product	08/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	08/01/2022

Labeler - Kenvue Brands LLC (118772437)