AVEENO BABY ECZEMA THERAPY MOISTURIZING CREAM CLUBTRAY- colloidal oatmeal kit

Aveeno Baby Eczema Therapy Moisturizing Cream Clubtray by

Drug Labeling and Warnings

Aveeno Baby Eczema Therapy Moisturizing Cream Clubtray 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

Aveeno Baby Eczema Therapy Moisturizing Cream Clubtray

Drug Facts

Active ingredients

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

To open, twist off cap and 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 - Kit Package

Aveeno ®

baby

eczema therapy

PEDIATRICIAN & DERMATOLOGIST RECOMMENDED BRAND

FREE OF: PARABENS, PHTHALATES, PHENOXYETHANOL, STEROIDS

clinically proven to relieve itchy,

irritated skin due to eczema

ONE (1) Aveeno® Baby eczema therapy moisturizing cream 12 FL OZ (354 mL)

and ONE (1) Aveeno® Baby eczema therapy moisturizing cream NET WT. 7.3 OZ (206 g)

INGREDIENTS AND APPEARANCE

AVEENO BABY ECZEMA THERAPY MOISTURIZING CREAM CLUBTRAY 
colloidal oatmeal kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0921

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0921-9	1 in 1 CARTON; Type 0: Not a Combination Product	03/01/2024

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE	354 mL
Part 2	1 TUBE	206 g

Part 1 of 2

AVEENO BABY ECZEMA THERAPY MOISTURIZING 
oatmeal cream

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

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

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

Part 2 of 2

AVEENO BABY ECZEMA THERAPY MOISTURIZING 
oatmeal cream

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0404-7	206 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	06/01/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	03/01/2024

Labeler - Kenvue Brands LLC (118772437)