AVEENO BABY CALMING COMFORT BATH PLUS SET- dimethicone kit

Aveeno Baby by

Drug Labeling and Warnings

Aveeno Baby 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 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

SPL UNCLASSIFIED SECTION

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)

INGREDIENTS AND APPEARANCE

AVEENO BABY  CALMING COMFORT BATH PLUS SET
dimethicone kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0139

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0139-9	1 in 1 PACKAGE, COMBINATION	11/01/2016

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

Part 1 of 2

AVEENO BABY CALMING COMFORT BATH 
other 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	Glyceryl Oleate (UNII: 4PC054V79P)
INGR	Sodium Benzoate (UNII: OJ245FE5EU)
INGR	CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
INGR	Butylene Glycol (UNII: 3XUS85K0RA)
INGR	Sodium Hydroxide (UNII: 55X04QC32I)
INGR	OAT (UNII: Z6J799EAJK)
INGR	POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)

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		09/01/2013

Part 2 of 2

AVEENO BABY CALMING COMFORT 
dimethicone lotion

Product Information
Item Code (Source)	NDC: 69968-0038
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 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0038-8	227 mL 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 final	part347	06/09/2002

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	11/01/2016

Labeler - Johnson & Johnson Consumer Inc. (002347102)