AVEENO BABY CALMING COMFORT- dimethicone lotion 
Johnson & Johnson Consumer 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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Aveeno ® Baby Calming Comfort ® Lotion

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

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)

PRINCIPAL DISPLAY PANEL - 227 g Tube Label
AVEENO BABY CALMING COMFORT 
dimethicone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0656
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE12 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69968-0656-8227 g in 1 TUBE; Type 0: Not a Combination Product06/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34706/01/2020
Labeler - Johnson & Johnson Consumer Inc. (118772437)

Revised: 1/2023
Document Id: f1daa508-7d20-806d-e053-2995a90a577a
Set id: 029fbae2-06ad-4fe9-b542-834686c5cb97
Version: 2
Effective Time: 20230109
 
Johnson & Johnson Consumer Inc.