Drug Facts

Active Ingredient

Colloidal Oatmeal 1%

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

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

Distributed by:
Kenvue Brands LLC
Summit, NJ 07901

PRINCIPAL DISPLAY PANEL - 28 g Jar Label

Recommended by

Pediatricians & Dermatologists

Aveeno®

baby

NET WT. 1 OZ (28 g)

eczema
therapy

nighttime balm

colloidal oatmeal skin
protectant + ceramide

clinically proven to

relieve itchy, dry, irritated

skin due to eczema

ACCEPTED

e

NATIONALECZEMA.ORG

NATIONAL

ECZEMA

ASSOCIATION

Aveeno_1

AVEENO BABY ECZEMA THERAPY NIGHTTIME BALM
oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69968-0540
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ISOCETYL ALCOHOL (UNII: 1800H64066)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETYL ALCOHOL (UNII: 936JST6JCN)
BENZYL ALCOHOL (UNII: LKG8494WBH)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)
BENZOIC ACID (UNII: 8SKN0B0MIM)
STEARIC ACID (UNII: 4ELV7Z65AP)
DIBASIC POTASSIUM PHOSPHATE (UNII: CI71S98N1Z)
POTASSIUM PHOSPHATE, UNSPECIFIED FORM (UNII: B7862WZ632)
P-ANISIC ACID (UNII: 4SB6Y7DMM3)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
OAT KERNEL OIL (UNII: 3UVP41R77R)
CERAMIDE NP (UNII: 4370DF050B)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
OAT (UNII: Z6J799EAJK)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69968-0540-2	28 g in 1 JAR; Type 0: Not a Combination Product	03/25/2019
2	NDC:69968-0540-5	156 g in 1 JAR; Type 0: Not a Combination Product	03/25/2019
3	NDC:69968-0540-1	312 g in 1 JAR; Type 0: Not a Combination Product	03/25/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M016	03/25/2019

Labeler - Kenvue Brands LLC (118772437)

Aveeno ® baby eczema therapy nighttime balm