AVEENO ECZEMA THERAPY HAND AND FACE- oatmeal cream
Johnson & Johnson Consumer Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Aveeno ® Eczema Therapy Hand and Face Cream

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

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

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

PRINCIPAL DISPLAY PANEL - 73.7 g Tube Label

NEW LOOK
SAME GREAT FORMULA

Aveeno ®
Eczema
Therapy
hand and face cream
colloidal oatmeal • skin protectant

Relieves Dry, Itchy,
Irritated Skin

Convenient
on the go size
Steroid free &
fragrance - free

ACCEPTED
e
NATIONAL ECZEMA .ORG

NATIONAL
Eczema
ASSOCIATION

with
COLLOIDAL
OATMEAL
& CERAMIDE

net wt. 2.6 OZ (73.7 g)

PRINCIPAL DISPLAY PANEL - 73.7 g Tube Label

AVEENO ECZEMA THERAPY HAND AND FACE
oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69968-0412
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
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69968-0412-2	73.7 g in 1 TUBE; Type 0: Not a Combination Product	07/01/2019	05/30/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	07/01/2019	05/30/2022

Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 10/2022

Document Id: ea593ca1-db11-28c8-e053-2a95a90ac505

Set id: eceab187-2220-4865-94f3-d078e4d99c07

Version: 3

Effective Time: 20221006

Johnson & Johnson Consumer Inc.