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Aveeno Baby Mommy and Me Gift Set

Medically reviewed on Feb 19, 2018

Dosage form: kit
Ingredients: ; Dimethicone 12mg in 1mL
Labeler: Johnson & Johnson Consumer Inc.
NDC Code: 69968-0166

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® Mommy and Me Gift Set

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, Allantoin, Sodium Chloride

Questions?

Call toll-free 866-4AVEENO or 215-273-8755 (collect) www.aveeno.com

Aveeno® Baby® Calming Comfort® Lotion

Drug Facts

Active ingredient

Dimethicone 1.2%

Purpose

Skin protectant

Uses
  • Temporarily protects and helps relieve 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, Fragrance, Sodium Chloride

Questions?

Call toll-free 866-4AVEENO or 215-273-8755 (collect) www.aveeno.com

Distributed By:
JOHNSON & JOHNSON
CONSUMER INC.

Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - Kit Package

Aveeno
Baby®

PEDIATRICIAN
Aveeno®
RECOMMENDED®

mommy & me gift set
regalo para mamá y bebé

FOR BABY Daily Moisture Lotion net wt. 8 oz (227 g) • Wash & Shampoo 8 fl oz (236 mL)
CALMING COMFORT® Lotion net wt. 8 oz (227 g) • CALMING COMFORT® Bath 8 fl oz (236 mL)

FOR MOMMY Stress Relief Moisturizing Lotion 12 fl oz (354 mL) • Stress Relief Body Wash 12 fl
oz (354 mL)
only at BABIESRUS®

Established Pharmacological Class
SubstancePharmacological Class
Aveeno Baby Wash and ShampooBABY SHAMPOOS
Aveeno Stress Relief Body WashBATH SOAPS AND DETERGENTS
Aveeno Baby Calming Comfort BathBATH SOAPS AND DETERGENTS
Aveeno Active naturals Stress Relief MoisturisingLOTIONS, OILS, POWDERS, AND CREAMS
AVEENO BABY MOMMY AND ME  GIFT SET
dimethicone kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0166
Packaging
#Item CodePackage Description
1NDC:69968-0166-91 KIT in 1 PACKAGE, COMBINATION
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 236 mL
Part 21 BOTTLE 354 mL
Part 31 TUBE 227 mL
Part 41 BOTTLE 236 mL
Part 51 TUBE 227 mL
Part 61 BOTTLE, PUMP 354 mL
Part 1 of 6
AVEENO BABY WASH AND SHAMPOO 
solution
Product Information
Route of AdministrationTOPICALDEA Schedule    
Ingredients
Ingredient NameQuantity
Water 
Cocamidopropyl Betaine 
Sodium Lauroamphoacetate 
Glycerin 
Coco Glucoside 
Sodium Chloride 
Citric Acid Monohydrate 
Sodium Benzoate 
Glyceryl Oleate 
Sodium Hydroxide 
Butylene Glycol 
Oat 
Packaging
#Item CodePackage Description
1236 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
COSMETIC06/01/2010
Part 2 of 6
AVEENO STRESS RELIEF BODY WASH 
solution
Product Information
Route of AdministrationTOPICALDEA Schedule    
Ingredients
Ingredient NameQuantity
Water 
Glycerin 
Cocamidopropyl Betaine 
Sodium Laureth-3 Sulfate 
Oatmeal 
Edetate Sodium 
Glycol Distearate 
Quaternium-15 
Myristyl Alcohol 
Citric Acid Monohydrate 
Packaging
#Item CodePackage Description
1354 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
COSMETIC01/16/2006
Part 3 of 6
AVEENO BABY DAILY MOISTURE 
dimethicone lotion
Product Information
Item Code (Source)NDC:58232-0104
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (Dimethicone) Dimethicone12 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Glycerin 
Distearyldimonium Chloride 
Petrolatum 
Isopropyl Palmitate 
Cetyl Alcohol 
Oatmeal 
Benzyl Alcohol 
Allantoin 
Sodium Chloride 
Packaging
#Item CodePackage Description
1NDC:58232-0104-2227 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34708/09/2011
Part 4 of 6
AVEENO BABY CALMING COMFORT BATH 
solution
Product Information
Route of AdministrationTOPICALDEA Schedule    
Ingredients
Ingredient NameQuantity
Water 
Cocamidopropyl Betaine 
Decyl Glucoside 
Coco Glucoside 
Sodium Lauroamphoacetate 
Oat 
Glyceryl Oleate 
Glycerin 
Sodium Benzoate 
Sodium Chloride 
Citric Acid Monohydrate 
Sodium Hydroxide 
Packaging
#Item CodePackage Description
1236 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
COSMETIC12/01/2003
Part 5 of 6
AVEENO BABY CALMING COMFORT 
dimethicone lotion
Product Information
Item Code (Source)NDC:58232-0211
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (Dimethicone) Dimethicone12 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Glycerin 
Distearyldimonium Chloride 
Petrolatum 
Isopropyl Palmitate 
Cetyl Alcohol 
Oatmeal 
Benzyl Alcohol 
Sodium Chloride 
Packaging
#Item CodePackage Description
1NDC:58232-0211-1227 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34712/01/2010
Part 6 of 6
AVEENO ACTIVE NATURALS STRESS RELIEF MOISTURISING 
lotion
Product Information
Route of AdministrationTOPICALDEA Schedule    
Ingredients
Ingredient NameQuantity
Water 
Glycerin 
Distearyldimonium Chloride 
Petrolatum 
Isopropyl Palmitate 
Cetyl Alcohol 
Dimethicone 
Oatmeal 
Sodium Chloride 
Benzyl Alcohol 
Packaging
#Item CodePackage Description
1354 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
COSMETIC01/16/2006
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34702/10/2016
Labeler - Johnson & Johnson Consumer Inc. (002347102)

 
Johnson & Johnson Consumer Inc.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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