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

Aveeno_001
(click image for full-size original)
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.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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