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 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 - Kit Packet

Aveeno ®
baby
calming comfort ®
bath + lotion set

18 FL OZ (532 mL)

NET WT. 8 OZ (227 g)

AVEENO BABY CALMING COMFORT BATH PLUS SET
dimethicone kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69968-0631

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69968-0631-9	1 in 1 PACKET	08/03/2020

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 TUBE	227 g
Part 2	1 BOTTLE	532 mL

Part 1 of 2

AVEENO BABY CALMING COMFORT
dimethicone lotion

Product Information
Item Code (Source)	NDC:69968-0656
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	12 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69968-0656-8	227 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M016	06/01/2020

Part 2 of 2

AVEENO BABY CALMING COMFORT BATH
baby shampoos [baby products] solution

Product Information
Route of Administration	TOPICAL

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
INGR	WATER (UNII: 059QF0KO0R)
INGR	COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
INGR	SODIUM LAUROAMPHOACETATE (UNII: SLK428451L)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	COCO GLUCOSIDE (UNII: ICS790225B)
INGR	SODIUM CHLORIDE (UNII: 451W47IQ8X)
INGR	CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
INGR	CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
INGR	SODIUM BENZOATE (UNII: OJ245FE5EU)
INGR	GLYCERYL OLEATE (UNII: 4PC054V79P)
INGR	POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)
INGR	SODIUM HYDROXIDE (UNII: 55X04QC32I)
INGR	OAT (UNII: Z6J799EAJK)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		532 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Cosmetic		06/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M016	08/03/2020

Labeler - Johnson & Johnson Consumer Inc. (118772437)

Aveeno ® baby calming comfort ® bath plus lotion set Aveeno baby calming comfort ® lotion