AVEENO BABY DAILY CARE SET- dimethicone kit

Aveeno Baby Daily Care Set by

Drug Labeling and Warnings

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

Drug Details [pdf]

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Drug Facts

Active ingredient

Dimethicone 1.2%

Purpose

Skin protectant

Uses

• Helps prevent and temporarily protects chafed, chapped or cracked skin.

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

• 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, Sodium Chloride, Allantoin

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 Package Label

RECOMMENDED BY
PEDIATRICIANS
& DERMATOLOGISTS
Aveeno ®
baby
daily care set
daily nourishment for
baby's sensitive skin
cleanse gently                     protect and moisturize
12 FL OZ (354mL)              12 FL OZ (354mL)

INGREDIENTS AND APPEARANCE

AVEENO BABY DAILY CARE SET 
dimethicone kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0632

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0632-9	1 in 1 PACKAGE	11/30/2020

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE, PUMP	354 mL
Part 2	1 BOTTLE, PUMP	354 mL

Part 1 of 2

AVEENO BABY DAILY MOISTURE 
dimethicone lotion

Product Information
Item Code (Source)	NDC: 69968-0441
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
GLYCERIN (UNII: PDC6A3C0OX)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
PETROLATUM (UNII: 4T6H12BN9U)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
CETYL ALCOHOL (UNII: 936JST6JCN)
WATER (UNII: 059QF0KO0R)
OATMEAL (UNII: 8PI54V663Y)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ALLANTOIN (UNII: 344S277G0Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0441-2	354 mL in 1 BOTTLE, PUMP; 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	08/01/2001

Part 2 of 2

AVEENO BABY DAILY MOISTURE WASH AND SHAMPOO 
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	SODIUM HYDROXIDE (UNII: 55X04QC32I)
INGR	OAT (UNII: Z6J799EAJK)
INGR	GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		354 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		07/06/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	11/30/2020

Labeler - Kenvue Brands LLC (118772437)