OTC Medication Information: Aveeno Baby Welcome Little One Gift Basket

AVEENO BABY WELCOME LITTLE ONE GIFT BASKET- 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.

Aveeno _® baby daily moisture lotion

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

• To open, twist off 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, Sodium Chloride, Allantoin

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 Package

RECOMMENDED BY

PEDIATRICIANS

& DERMATOLOGISTS

Aveeno®

baby

NEW

Includes

1oz travel size

welcome little one

gift basket

Everyday gentle essentials to calm, cleanse, and moisturize baby

Aveeno®

baby

Gift basket

Includes :

Daily Moisture Wash &

Shampoo (8 fl oz & 1 fl oz)

Gently cleanses and

nourishes baby’s hair

and sensitive skin

CALMING COMFORT® Bath

(8 fl oz)

Gently cleanses baby’s

delicate skin and helps

calm baby before bedtime

Daily Moisture Lotion

(8 fl oz)

Protects and moisturizes

baby’s sensitive skin for

24hrs

Sensitive All Over Wipes

(64 ct)

Wipes away dirt and germs

and contains oat extract and

aloe

Established Pharmacological Class

Substance Pharmacological Class Aveeno Baby Daily Moisture Wash and Shampoo Baby Shampoos Aveeno Baby Daily Moisture Wash and Shampoo Baby Shampoos Aveeno Baby Calming Comfort Bath Baby Shampoos Aveeno Baby Sensitive All Over Wipes Other Personal Cleanliness Products

AVEENO BABY WELCOME LITTLE ONE GIFT BASKET dimethicone kit

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69968-0766

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:69968-0766-9 1 KIT in 1 PACKAGE None

Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 TUBE 227 g Part 2 1 BOTTLE 236 mL Part 3 0 BOTTLE 29 mL Part 4 1 BOTTLE 236 mL Part 5 1 PACKET 64

Part 1 of 5 AVEENO BABY DAILY MOISTURE dimethicone lotion

Product Information Item Code (Source) NDC:69968-0679 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (DIMETHICONE) DIMETHICONE 12 mg in 1 g

Inactive Ingredients Ingredient Name Strength PETROLATUM OAT BENZYL ALCOHOL ALLANTOIN DISTEARYLDIMONIUM CHLORIDE CETYL ALCOHOL SODIUM CHLORIDE ISOPROPYL PALMITATE WATER GLYCERIN

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:69968-0679-8 227 g in 1 TUBE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 08/01/2011

Part 2 of 5 AVEENO BABY DAILY MOISTURE WASH AND SHAMPOO solution

Product Information Route of Administration TOPICAL DEA Schedule

Ingredients Ingredient Name Quantity WATER COCAMIDOPROPYL BETAINE SODIUM LAUROAMPHOACETATE GLYCERIN COCO GLUCOSIDE SODIUM CHLORIDE CITRIC ACID MONOHYDRATE CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) SODIUM BENZOATE GLYCERYL MONOOLEATE SODIUM HYDROXIDE GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) OAT

Packaging # Item Code Package Description Multilevel Packaging 1 236 mL in 1 BOTTLE None

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

Part 3 of 5 AVEENO BABY DAILY MOISTURE WASH AND SHAMPOO solution

Product Information Route of Administration TOPICAL DEA Schedule

Ingredients Ingredient Name Quantity WATER COCAMIDOPROPYL BETAINE SODIUM LAUROAMPHOACETATE GLYCERIN COCO GLUCOSIDE SODIUM CHLORIDE CITRIC ACID MONOHYDRATE CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) SODIUM BENZOATE GLYCERYL MONOOLEATE SODIUM HYDROXIDE GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) OAT

Packaging # Item Code Package Description Multilevel Packaging 1 236 mL in 1 BOTTLE None

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

Part 4 of 5 AVEENO BABY CALMING COMFORT BATH solution

Product Information Route of Administration TOPICAL DEA Schedule

Ingredients Ingredient Name Quantity SODIUM LAUROAMPHOACETATE POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) WATER SODIUM BENZOATE SODIUM CHLORIDE COCAMIDOPROPYL BETAINE SODIUM HYDROXIDE COCO GLUCOSIDE CARBOMER INTERPOLYMER TYPE A (55000 CPS) CITRIC ACID MONOHYDRATE GLYCERIN OAT GLYCERYL OLEATE

Packaging # Item Code Package Description Multilevel Packaging 1 236 mL in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 06/01/2010

Part 5 of 5 AVEENO BABY SENSITIVE ALL OVER WIPES cloth

Product Information Route of Administration TOPICAL DEA Schedule

Ingredients Ingredient Name Quantity ALOE VERA LEAF GLYCERIN GLYCERYL OLEATE CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE LAURYL GLUCOSIDE CAPRYLYL GLYCOL CITRIC ACID MONOHYDRATE SODIUM HYDROXIDE SODIUM BENZOATE WATER OAT COCO GLUCOSIDE

Packaging # Item Code Package Description Multilevel Packaging 1 64 CLOTH in 1 PACKET None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 06/14/2019

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 06/01/2022

Labeler — Johnson & Johnson Consumer Inc. (118772437)

Revised: 01/2023 Johnson & Johnson Consumer Inc.