AVEENO BABY CALMING COMFORT BATH PLUS SET- dimethicone 
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 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)

Principal Display Panel - 532 mL Kit Package
AVEENO BABY  CALMING COMFORT BATH PLUS SET
dimethicone kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0139
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69968-0139-91 in 1 PACKAGE, COMBINATION11/01/201611/01/2020
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 
other baby products solution
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWater (UNII: 059QF0KO0R)  
INGRCocamidopropyl Betaine (UNII: 5OCF3O11KX)  
INGRSodium Lauroamphoacetate (UNII: SLK428451L)  
INGRGlycerin (UNII: PDC6A3C0OX)  
INGRCoco Glucoside (UNII: ICS790225B)  
INGRSodium Chloride (UNII: 451W47IQ8X)  
INGRCITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
INGRGlyceryl Oleate (UNII: 4PC054V79P)  
INGRSodium Benzoate (UNII: OJ245FE5EU)  
INGRCARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
INGRButylene Glycol (UNII: 3XUS85K0RA)  
INGRSodium Hydroxide (UNII: 55X04QC32I)  
INGROAT (UNII: Z6J799EAJK)  
INGRPOLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1532 mL in 1 BOTTLE; Type 0: Not a Combination Product
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 AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone12 mg  in 1 mL
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)  
OAT (UNII: Z6J799EAJK)  
Benzyl Alcohol (UNII: LKG8494WBH)  
Sodium Chloride (UNII: 451W47IQ8X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69968-0038-8227 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34706/01/200211/07/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34711/01/201611/01/2020
Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 10/2020
Document Id: 9a5fee8f-b972-42cb-92cc-ab2f85ce9893
Set id: 98f8e026-dae5-40fc-8eaa-f4b3b91208f5
Version: 3
Effective Time: 20201001
 
Johnson & Johnson Consumer Inc.