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 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:

• 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?

Call toll-free 866-4AVEENO or 215-273-8755 (collect) or visit www.aveeno.com

SPL UNCLASSIFIED SECTION

Distributed by:
JOHNSON & JOHNSON
CONSUMER INC.
Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - 206 g Tube Label

PEDIATRICIAN
RECOMMENDED BRAND

Aveeno
Baby®
Eczema
Therapy
MOISTURIZING CREAM
colloidal oatmeal skin protectant

Relieves dry, itchy, irritated skin
due to eczema
Clinically shown to soothe babies
with eczema
Steroid-free, Fragrance-free,
Paraben-free, Phthalate-free

ACCEPTED
e
NATIONALECZEMA.ORG

NATIONAL
ECZEMA
ASSOCIATION

NET WT. 7.3 OZ. (206g)

INGREDIENTS AND APPEARANCE

AVEENO BABY ECZEMA THERAPY MOISTURIZING 
oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0404
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
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
Panthenol (UNII: WV9CM0O67Z)
Distearyldimonium Chloride (UNII: OM9573ZX3X)
Petrolatum (UNII: 4T6H12BN9U)
Isopropyl Palmitate (UNII: 8CRQ2TH63M)
Cetyl Alcohol (UNII: 936JST6JCN)
Dimethicone (UNII: 92RU3N3Y1O)
Oat Kernel Oil (UNII: 3UVP41R77R)
Steareth-20 (UNII: L0Q8IK9E08)
Benzalkonium Chloride (UNII: F5UM2KM3W7)
Ceramide NP (UNII: 4370DF050B)
Sodium Chloride (UNII: 451W47IQ8X)
Oat (UNII: Z6J799EAJK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0404-5	141 g in 1 TUBE; Type 0: Not a Combination Product	06/01/2010
2	NDC: 69968-0404-7	206 g in 1 TUBE; Type 0: Not a Combination Product	06/01/2010
3	NDC: 69968-0404-1	14 g in 1 TUBE; Type 0: Not a Combination Product	06/01/2010
4	NDC: 69968-0404-2	354 g 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 FINAL	part347	06/01/2010

Labeler - Johnson & Johnson Consumer Inc. (002347102)