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Aveeno Baby Calming Comfort by Les Emballages Knowlton Inc.

Medically reviewed on November 7, 2017

Dosage form: lotion
Ingredients: DIMETHICONE 12mg in 1mL
Labeler: Les Emballages Knowlton Inc.
NDC Code: 54565-1301

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.

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.

Do not use on
  • Deep or puncture wounds
  • Animal bites
  • Serious burns

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
  • 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?

866-4AVEENO; Outside US, dial collect 215-273-8755 www.aveeno.com

Distributed in the US by:
JOHNSON & JOHNSON
CONSUMER PRODUCTS
COMPANY

Division of Johnson & Johnson
Consumer Companies, Inc.
Skillman, NJ 08558-9418

PRINCIPAL DISPLAY PANEL - 532 mL Bottle Label

Aveeno®

Baby®

PEDIATRICIAN

RECOMMENDED®

LAVENDER & VANILLA

Calming Comfort ® Lotion

Dimethicone Skin Protectant

with Natural Colloidal Oatmeal

Helps Protect Delicate Skin

Moisturizes for 24 Hours

Helps Calm Babies before Bedtime

18 Fl. Oz. (532 mL)

AVEENO BABY CALMING COMFORT 
dimethicone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54565-1301
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (DIMETHICONE) DIMETHICONE12 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
GLYCERIN 
DISTEARYLDIMONIUM CHLORIDE 
PETROLATUM 
ISOPROPYL PALMITATE 
CETYL ALCOHOL 
OATMEAL 
BENZYL ALCOHOL 
SODIUM CHLORIDE 
Packaging
#Item CodePackage Description
1NDC:54565-1301-1227 mL in 1 TUBE
2NDC:54565-1301-2532 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34701/01/200209/01/2018
Labeler - Les Emballages Knowlton Inc. (248704645)
Establishment
NameAddressID/FEIOperations
Les Emballages Knowlton Inc248704645manufacture(54565-1301)

 
Les Emballages Knowlton Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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