Drug Facts

Active ingredient

Dimethicone 1.2%

Purpose

Skin protectant

Uses

Temporarily protects and helps relieve chafed, chapped, or cracked skin
Helps prevent and protect from the drying effects of wind and cold weather.

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.

Do not use on

Deep or puncture wounds
Animal bites
Serious burns .

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

Store at room temperature.
Remove quality seal. Do not use if quality seal is broken.

Inactive ingredients

Water , Glycerin, Distearyldimonium Chloride ,Petrolatum, Isopropyl Palmitate, Cetyl Alcohol, Avena Sativa (Oat) Kernel Flour, Benzyl Alcohol, Fragrance, Sodium Chloride

Questions?

866-428-3366; Outside US, dial collect 215-273-8755 visit www.aveeno.com

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

PRINCIPAL DISPLAY PANEL - 532 mL Bottle Label

RECOMMENDED BY
PEDIATRICIANS
& DERMATOLOGIST
Aveeno ®
New
Look

baby
New Gentle
Fragrance
calming comfort ®
lotion
natural oatmeal
+ lavender scent
dimethicone skin protectant
moisturizes baby's
skin for 24hrs
helps calm baby
before bedtime
lavender &
vanilla scented
18 FL OZ (532 mL)

PRINCIPAL DISPLAY PANEL - 532 mL Bottle Label

AVEENO BABY CALMING COMFORT
dimethicone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69968-0629
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	12 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
PETROLATUM (UNII: 4T6H12BN9U)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
CETYL ALCOHOL (UNII: 936JST6JCN)
OATMEAL (UNII: 8PI54V663Y)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69968-0629-1	532 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/01/2020
2	NDC:69968-0629-8	227 mL in 1 TUBE; Type 0: Not a Combination Product	06/01/2020	06/02/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	06/01/2020

Labeler - Johnson & Johnson Consumer Inc. (118772437)

Aveeno Baby Calming Comfort Lotion