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

• do not use if quality seal is broken or missing
• protect from excessive heat (40°C/104°F)

Inactive Ingredients

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

Questions?

866-428-3366; Outside US, dial collect 215-273-8755 www.aveeno.com

SPL UNCLASSIFIED SECTION

Distributed by:

JOHNSON & JOHNSON

CONSUMER INC.

Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - 312 g Jar

Aveeno®

Eczema Therapy

NIGHTTIME ITCH RELIEF BALM

Colloidal Oatmeal Skin Protectant Cream

Soothes Itchy,

Eczema-Prone Skin

Itch relief that starts working instantly

with intense, long lasting moisture

STEROID FREE

FRAGRANCE FREE

ACCEPTED

e

National

Eczema

Association

DERMATOLOGIST RECOMMENDED BRAND

COLLOIDAL OATMEAL & CERAMIDE

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)
ISOCETYL ALCOHOL (UNII: 1800H64066)
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 final	M016	08/01/2022

Labeler - Johnson & Johnson Consumer Inc. (118772437)