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Aveeno Baby Mommy and Me Gift Set

Dosage form: kit
Ingredients: ; Zinc Oxide 130mg in 1g; Dimethicone 12mg in 1mL
Labeler: Johnson & Johnson Consumer Inc.
NDC Code: 58232-9914

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 Soothing Relief Diaper Rash Cream

Drug Facts

Active ingredient(s)

Zinc Oxide 13%

Purposes

Skin Protectant

Uses
  • Helps treat and prevent diaper rash
  • Protects chafed skin due to diaper rash
  • Helps seal out wetness

Warnings

For external use only.

When using this product

  • Avoid contact with eyes

Stop use and ask a doctor if

  • Condition worsens or does not improve within 7 days

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions
  • Change wet or soiled diapers promptly
  • Clean the diaper area and allow to dry
  • Apply cream liberally as often as necessary, with each diaper change, especially at bedtime or any time exposure to wet diapers may be prolonged.

Other information

Do not use if quality seal is broken.

Inactive ingredients

Avena Sativa (Oat) Kernel Extract, Beeswax, Benzoic Acid, Dimethicone, Epilobium Angustifolium Flower/Leaf/Stem Extract, Glycerin, Methylparaben, Microcrystalline Wax, Mineral Oil, Oenothera Biennis (Evening Primrose) Seed Extract, Potassium Hydroxide, Propylparaben, Sorbitan Sesquioleate, Synthetic Beeswax, Water

Questions?

Call 1-866-428-3366 or visit www.aveeno.com

Aveeno Baby Daily Moisture Lotion

Drug Facts

Active ingredients

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 immediately.

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?

1 -866-428-3366 or visit www.aveeno.com

 

Aveeno Baby Calming Comfort Lotion

Drug Facts

Active ingredients

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 immediately.

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?

1 -866-428-3366 or visit www.aveeno.com

PRINCIPAL DISPLAY PANEL - Kit Package

Aveeno®
Baby®

PEDIATRICIAN
RECOMMENDED

mommy & me
gift set

FOR BABY Daily Moisture Lotion net wt. 8 oz. (226 g) • Wash & Shampoo 8 fl. Oz. (236 mL)
CALMING COMFORT® Lotion net. Wt. 8 oz. (226 g) • CALMING COMFORT® Bath 8 fl. oz.(236 mL)
Soothing Relief Diaper Rash Cream net. Wt. 1.8 oz. (51 g)
FOR MOMMY Stress Relief Moisturizing Lotion 12 fl. oz. (354 mL) • Stress Relief Body Wash 2 fl. oz. (59 mL)

Established Pharmacological Class
SubstancePharmacological Class
Aveeno Baby WashBABY SHAMPOOS
Aveeno Baby Calming Comfort BathBATH SOAPS AND DETERGENTS
Aveeno Stress ReliefLOTIONS, OILS, POWDERS, AND CREAMS
Aveeno Stress Relief Body WashBATH SOAPS AND DETERGENTS
AVEENO BABY MOMMY AND ME   GIFT SET
zinc oxide and dimethicone kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58232-9914
Packaging
#Item CodePackage Description
1NDC:58232-9914-91 KIT in 1 PACKAGE, COMBINATION
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 236 mL
Part 21 TUBE 51 g
Part 31 TUBE 226 mL
Part 41 BOTTLE 236 mL
Part 51 TUBE 226 mL
Part 61 BOTTLE 354 mL
Part 71 BOTTLE 59 mL
Part 1 of 7
AVEENO BABY WASH 
inert liquid
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
COSMETIC11/19/2012
Part 2 of 7
AVEENO BABY SOOTHING RELIEF DIAPER RASH 
zinc oxide cream
Product Information
Item Code (Source)NDC:58232-0631
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (Zinc Oxide) Zinc Oxide130 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Oat 
Yellow Wax 
Benzoic Acid 
Dimethicone 
Epilobium Angustifolium Flowering Top 
Glycerin 
Methylparaben 
Microcrystalline Wax 
Mineral Oil 
Evening Primrose Oil 
Potassium Hydroxide 
Propylparaben 
Sorbitan Sesquioleate 
Water 
Packaging
#Item CodePackage Description
1NDC:58232-0631-251 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34708/17/2011
Part 3 of 7
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:58232-0104-2226 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34708/09/2011
Part 4 of 7
AVEENO BABY CALMING COMFORT BATH 
inert liquid
Product Information
Route of AdministrationTOPICALDEA Schedule    
Ingredients
Ingredient NameQuantity
Water 
Cocamidopropyl Betaine 
Decyl Glucoside 
PEG-80 Sorbitan Laurate 
Disodium Lauroamphodiacetate 
DI-PPG-2 Myreth-10 Adipate 
Oat 
Coco Glucoside 
PEG-150 Distearate 
Glycol Distearate 
Glycerin 
Edetate Sodium 
Laureth-4 
Polyethylene Glycol 600000 
Quaternium-15 
Sodium Hydroxide 
Citric Acid Monohydrate 
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 7
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 
Allantoin 
Sodium Chloride 
Packaging
#Item CodePackage Description
1NDC:58232-0211-1226 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34712/01/2010
Part 6 of 7
AVEENO STRESS RELIEF 
inert 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
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
COSMETIC01/16/2006
Part 7 of 7
AVEENO STRESS RELIEF BODY WASH 
inert liquid
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
159 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
COSMETIC12/26/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34705/10/201302/18/2018
Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 02/2016
 
Johnson & Johnson Consumer Inc.

← See all Aveeno Baby Mommy and Me Gift Set brands

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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