AVEENO BABY ECZEMA THERAPY MOISTURIZING- oatmeal cream

Aveeno Baby Eczema Therapy Moisturizing by

Drug Labeling and Warnings

Aveeno Baby Eczema Therapy Moisturizing by is a Otc medication manufactured, distributed, or labeled by Kenvue Brands LLC. 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:

• 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

• Remove quality seal. Do not use if quality seal is broken.
• For use on mild to moderate eczema or as directed by a physician.
• Store at room temperature.

Inactive ingredients

Water, Glycerin, Panthenol, Distearyldimonium Chloride, Petrolatum, Isopropyl Palmitate, Cetyl Alcohol, Dimethicone, Avena Sativa (Oat) Kernel Oil, Steareth-20, Benzalkonium Chloride, Ceramide NP, Sodium Chloride, 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 - 354 mL Bottle Label

RECOMMENDED BY

PEDIATRICIANS

& DERMATOLOGISTS

Aveeno®

baby

NEW

LOOK

Same Great

Formula

eczema

therapy

moisturizing cream

colloidal oatmeal skin

protectant + vitamin B5

clinically proven to

relieve itchy, irritated

skin due to eczema

ACCEPTED

e

NATIONALECZEMA.ORG

National

Eczema

Association

fragrance-free & steroid-free

hypoallergenic

12 FL OZ (354 mL)

INGREDIENTS AND APPEARANCE

AVEENO BABY ECZEMA THERAPY MOISTURIZING 
oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0923
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 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PANTHENOL (UNII: WV9CM0O67Z)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
PETROLATUM (UNII: 4T6H12BN9U)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
CETYL ALCOHOL (UNII: 936JST6JCN)
OAT KERNEL OIL (UNII: 3UVP41R77R)
STEARETH-20 (UNII: L0Q8IK9E08)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
CERAMIDE NP (UNII: 4370DF050B)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
OAT (UNII: Z6J799EAJK)
DIMETHICONE (UNII: 92RU3N3Y1O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0923-2	354 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	04/01/2013

Labeler - Kenvue Brands LLC (118772437)