Aveeno Baby Soothing Relief Diaper Rash Cream Fragrance Free

Drug Labeling and Warnings

Drug Details [pdf]

AVEENO BABY SOOTHING RELIEF DIAPER RASH  FRAGRANCE FREE- zinc oxide cream 
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.

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Aveeno Baby Soothing Relief Diaper Rash Cream Fragrance Free

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 immediately.

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 (willowherb), 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

Distributed by:
Johnson & Johnson
CONSUMER PRODUCTS COMPANY
Division of
Johnson &Johnson Consumer Companies, Inc.
Skillman, NJ 08558-9418

PRINCIPAL DISPLAY PANEL - 105g Tube Carton

New!
Aveeno®
Baby™

PEDIATRICIAN
RECOMMENDED™

FRAGRANCE FREE
Soothing Relief Diaper Rash Cream
With Soothing Oat Essence
and Natural Willowherb

Zinc Oxide Diaper Rash Cream

Formulated to Help Reduce
       Duration & Severity
Helps Soothe, Heal & Prevent
           Diaper Rash

NET WT. 3.7 OZ. (105g)

PRINCIPAL DISPLAY PANEL - 105g Tube Carton
AVEENO BABY SOOTHING RELIEF DIAPER RASH   FRAGRANCE FREE
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 58232-0631
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide130 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Oat (UNII: Z6J799EAJK)  
Yellow Wax (UNII: 2ZA36H0S2V)  
Benzoic Acid (UNII: 8SKN0B0MIM)  
Dimethicone (UNII: 92RU3N3Y1O)  
Epilobium Angustifolium Leaf (UNII: 7NV86426N2)  
Glycerin (UNII: PDC6A3C0OX)  
Methylparaben (UNII: A2I8C7HI9T)  
Microcrystalline Wax (UNII: XOF597Q3KY)  
Mineral Oil (UNII: T5L8T28FGP)  
Evening Primrose Oil (UNII: 3Q9L08K71N)  
Potassium Hydroxide (UNII: WZH3C48M4T)  
Propylparaben (UNII: Z8IX2SC1OH)  
Sorbitan Sesquioleate (UNII: 0W8RRI5W5A)  
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 58232-0631-35.1 g in 1 PACKET; Type 0: Not a Combination Product08/17/201112/01/2015
2NDC: 58232-0631-1105 g in 1 TUBE; Type 0: Not a Combination Product08/17/201112/01/2015
3NDC: 58232-0631-251 g in 1 TUBE; Type 0: Not a Combination Product08/17/201112/01/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34708/17/201112/01/2015
Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 1/2019
Document Id: 81de7cb0-bff4-4957-b586-3debff26875e
Set id: cfbdd799-6e1b-41d0-8e9d-3f91b9013699
Version: 3
Effective Time: 20190103