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 ® bath plus lotion set

Aveeno baby calming comfort ® lotion

Drug Facts

Active ingredient

Dimethicone 1.2%

Purpose

Skin protectant

Uses

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

Other information

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 - Kit Packet

Aveeno ®
baby

calming comfort ®
bath + lotion set

18 FL OZ (532 mL)

NET WT. 8 OZ (227 g)

PRINCIPAL DISPLAY PANEL - Kit Packet
AVEENO BABY CALMING COMFORT BATH PLUS SET 
dimethicone kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0631
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69968-0631-91 in 1 PACKET08/03/2020
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 227 g
Part 21 BOTTLE 532 mL
Part 1 of 2
AVEENO BABY CALMING COMFORT 
dimethicone lotion
Product Information
Item 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
BENZYL ALCOHOL (UNII: LKG8494WBH)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
PETROLATUM (UNII: 4T6H12BN9U)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
OATMEAL (UNII: 8PI54V663Y)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69968-0656-8227 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34706/01/2020
Part 2 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)  
INGRCARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
INGRSODIUM BENZOATE (UNII: OJ245FE5EU)  
INGRGLYCERYL OLEATE (UNII: 4PC054V79P)  
INGRPOLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)  
INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
INGROAT (UNII: Z6J799EAJK)  
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
Cosmetic06/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34708/03/2020
Labeler - Johnson & Johnson Consumer Inc. (118772437)

Revised: 1/2023
Document Id: eed88025-99c5-9c0e-e053-2a95a90ae312
Set id: 2c44fbc7-588f-41e2-953c-eebf24eecbf9
Version: 4
Effective Time: 20230109
 
Johnson & Johnson Consumer Inc.