AVEENO BABY CALMING COMFORT BATH PLUS SET- dimethicone kit

Aveeno Baby Calming Comfort Bath Plus Set by

Drug Labeling and Warnings

Aveeno Baby Calming Comfort Bath Plus Set by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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)

INGREDIENTS AND APPEARANCE

AVEENO BABY CALMING COMFORT BATH PLUS SET 
dimethicone kit

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

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

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
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

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

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0656-8	227 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
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)

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

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

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

Labeler - Kenvue Brands LLC (118772437)