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Aveeno Baby Calming comfort bath plus set

Dosage form: kit
Ingredients: ; Dimethicone 12mg in 1mL
Labeler: Johnson & Johnson Consumer Inc.
NDC Code: 69968-0139

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.

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 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 by:
JOHNSON & JOHNSON
CONSUMER INC.

Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - 532 mL Kit Package

Aveeno
Baby®

CALMING COMFORT®
BATH+LOTION SET

18 FL. OZ. (532 mL)      NET WT. 8 OZ. (227g)

Established Pharmacological Class
SubstancePharmacological Class
Aveeno Baby Calming Comfort BathOTHER BABY PRODUCTS
AVEENO BABY  CALMING COMFORT BATH PLUS SET
dimethicone kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0139
Packaging
#Item CodePackage Description
1NDC:69968-0139-91 KIT in 1 PACKAGE, COMBINATION
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 532 mL
Part 21 TUBE 227 mL
Part 1 of 2
AVEENO BABY CALMING COMFORT BATH 
solution
Product Information
Route of AdministrationTOPICALDEA Schedule    
Ingredients
Ingredient NameQuantity
Water 
Cocamidopropyl Betaine 
Sodium Lauroamphoacetate 
Glycerin 
Coco Glucoside 
Sodium Chloride 
CITRIC ACID MONOHYDRATE 
Glyceryl Oleate 
Sodium Benzoate 
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) 
Butylene Glycol 
Sodium Hydroxide 
OAT 
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) 
Packaging
#Item CodePackage Description
1532 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic09/01/2013
Part 2 of 2
AVEENO BABY CALMING COMFORT 
dimethicone lotion
Product Information
Item Code (Source)NDC:69968-0038
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 
OAT 
Benzyl Alcohol 
Sodium Chloride 
Packaging
#Item CodePackage Description
1NDC:69968-0038-8227 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34706/09/2002
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34711/01/2016
Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 11/2016
 
Johnson & Johnson Consumer Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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