AVEENO BABY CALMING COMFORT- dimethicone lotion

Aveeno Baby Calming Comfort by

Drug Labeling and Warnings

Aveeno Baby Calming Comfort 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

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

• To open, twist off cap, and remove quality seal. Do not use if quality seal is broken.
• Store at room temperature.

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 www.aveeno.com

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 227 g Tube Label

RECOMMENDED BY
PEDIATRICIANS
& DERMATOLOGISTS

Aveeno ®
Baby
NEW
LOOK
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

NET WT. 8 OZ (227 g)

INGREDIENTS AND APPEARANCE

AVEENO BABY CALMING COMFORT 
dimethicone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0656
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0656-8	227 g in 1 TUBE; Type 0: Not a Combination Product	06/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	06/01/2020

Labeler - Johnson & Johnson Consumer Inc. (118772437)