Aveeno ® baby soothing multi-purpose ointment

Aveeno Baby Soothing Multi-Purpose by

Drug Labeling and Warnings

Aveeno Baby Soothing Multi-Purpose by is a Otc medication manufactured, distributed, or labeled by KDC/ONE Development Corporation, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

AVEENO BABY SOOTHING MULTI-PURPOSE- white petrolatum ointment 
KDC/ONE Development Corporation, 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 multi-purpose ointment

Drug Facts

Active ingredient

White Petrolatum (70.3%)

Purpose

Skin Protectant

Uses

  • temporarily protects and helps relieve chapped or cracked skin
  • temporarily protects minor:
    • cuts
    • scrapes
    • burns
  • helps prevent and protect from the drying effects of wind and cold weather
  • helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash and helps seal out wetness

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

For diaper rash:

  • change wet or soiled diapers promptly
  • cleanse the diaper area and allow to dry
  • apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

For skin irritation: apply as needed

Other Information

  • protect from excessive Heat (40°C/104°F).
  • twist off cap, remove quality seal. Do not use if quality seal is broken.

Inactive ingredients

Mineral Oil, Paraffin, Avena Sativa (Oat) Kernel Flour, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate

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 - 133 g Tube Carton

RECOMMENDED BY

PEDIATRICIANS
& DERMATOLOGISTS

Aveeno ®

NEW
baby

soothing
multi-purpose
ointment

for sensitive skin
petrolatum skin protectant
prebiotic oat

soothes
irritated skin

helps prevent &
treat diaper rash

fragrance-free
hypoallergenic
& lanolin-free

NET WT. 4.7 OZ (133 g)

PRINCIPAL DISPLAY PANEL - 133 g Tube Carton
AVEENO BABY SOOTHING MULTI-PURPOSE 
white petrolatum ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 54565-1323
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM703 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL (UNII: T5L8T28FGP)  
PARAFFIN (UNII: I9O0E3H2ZE)  
OATMEAL (UNII: 8PI54V663Y)  
COCOA BUTTER (UNII: 512OYT1CRR)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 54565-1323-1133 g in 1 TUBE; Type 0: Not a Combination Product06/21/2021
2NDC: 54565-1323-93 in 1 PACKAGE06/21/2021
2133 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34706/21/2021
Labeler - KDC/ONE Development Corporation, Inc (204006464)
Establishment
NameAddressID/FEIBusiness Operations
KDC/ONE Development Corporation, Inc204006464analysis(54565-1323) , label(54565-1323) , manufacture(54565-1323) , pack(54565-1323)

Revised: 8/2021
Document Id: c9c43460-0649-e076-e053-2995a90ad11c
Set id: c55b9340-09db-5c42-e053-2a95a90a7fd9
Version: 2
Effective Time: 20210817