Drug Facts

Active Ingredient

Colloidal Oatmeal 2%

Purpose

Skin Protectant

Uses

Temporarily protects and helps relieve minor skin irritation and itching due to: • rashes • eczema

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

Sunburn Alert: This product contains an alpha hydroxy acid (AHA) that may increase your skin’s sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterwards.

Inactive Ingredients

Water, Glycerin, Isopropyl Palmitate, Butyrospermum Parkii (Shea) Butter, Isododecane, Vegetable Oil, Cetyl Alcohol, Sodium Hydroxide, Lactic Acid, Sodium Polyacrylate, Caprylyl Glycol, Avena Sativa (Oat) Kernel Oil, Cetearyl Olivate, Carbomer, 1,2-Hexanediol, Sorbitan Olivate, Hydrogenated Vegetable Oil, Euphorbia Cerifera (Candelilla) Wax, Avena Sativa (Oat) Kernel Extract, Tropolone

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 - 150mL Bottle Label

NEW!

Aveeno®

Eczema

Therapy

RESCUE RELIEF

TREATMENT

GEL CREAM

Colloidal Oatmeal Skin Protectant

Instantly soothes & cools

itchy, dry skin flare-ups

Clinically proven soothing relief

of itch, irritation, & dry skin

Developed with Eczema Consumers

STEROID & FRAGRANCE FREE

DERMATOLOGIST RECOMMENDED BRAND

2% COLLOIDAL OATMEAL AND SHEA BUTTER

5 fl oz (150mL)

Aveeno_001

AVEENO ECZEMA THERAPY RESCUE RELIEF TREATMENT
colloidal oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69968-0802
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	20 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
TROPOLONE (UNII: 7L6DL16P1T)
OAT KERNEL OIL (UNII: 3UVP41R77R)
SHEA BUTTER (UNII: K49155WL9Y)
CETYL ALCOHOL (UNII: 936JST6JCN)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
SORBITAN OLIVATE (UNII: MDL271E3GR)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
ISODODECANE (UNII: A8289P68Y2)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
LACTIC ACID (UNII: 33X04XA5AT)
CANDELILLA WAX (UNII: WL0328HX19)
OAT (UNII: Z6J799EAJK)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69968-0802-2	44 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	09/05/2022
2	NDC:69968-0802-5	150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	09/05/2022
3	NDC:69968-0802-1	14 mL in 1 TUBE; Type 0: Not a Combination Product	09/05/2022
4	NDC:69968-0802-9	12 in 1 CARTON	09/05/2022
4		14 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M016	09/05/2022

Labeler - Johnson & Johnson Consumer Inc. (118772437)

Aveeno Eczema Therapy Rescue Relief Treatment Gel Cream