AVEENO BABY CALMING COMFORT- dimethicone cream
Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, 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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Drug Facts

Active ingredient

Dimethicone 1.2%

Purposes

Skin Protectant

Uses

Helps prevent and temporarily protects chafed, chapped, or cracked skin

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 immediately.

Directions

Apply as needed.

Other information

To open, twist off cap and remove quality seal. Do not use if quality seal is broken.

Inactive ingredients

Avena sativa (oat) kernel flour, benzyl alcohol, cetyl alcohol, distearyldimonium chloride, fragrance, glycerin, isopropyl palmitate, petrolatum, sodium chloride, water

Questions?

1–877–298–2525

Distributed by:
Johnson & Johnson
CONSUMER COMPANIES, INC.
Skillman, NJ 08558-9418

PRINCIPAL DISPLAY PANEL - 227 g Tube

Aveeno®
Baby™

Pediatrician
Recommended™

LAVENDER & VANILLA
Calming Comfort™
Lotion

with Natural Colloidal Oatmeal

Dimethicone Skin Protectant

Helps Heal & Protect
Delicate Skin

Moisturizes for 24 Hours

Helps Calm Babies
before Bedtime

NET WT. 8 OZ. (227 g)

AVEENO BABY CALMING COMFORT
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58232-0211
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Dimethicone (Dimethicone)	Dimethicone	12.5 mg in 1 g

Inactive Ingredients
Ingredient Name	Strength
Oatmeal
Benzyl Alcohol
Cetyl Alcohol
Distearyldimonium Chloride
Glycerin
Isopropyl Palmitate
Petrolatum
Sodium Chloride
Water

Packaging
#	Item Code	Package Description
1	NDC:58232-0211-1	227 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	08/09/2011

Labeler - Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. (830803164)

Revised: 08/2011

Document Id: a6b11528-524c-4604-a561-88423c0cd360

Set id: 77a893f5-8b3e-4208-a805-5284278ad6c6

Version: 1

Effective Time: 20110811

Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc.