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Petrolatum

Basics 180.000/180AC Healing Ointment for Babies

Approved
Approval ID

833b5af7-8db1-4f88-bf4d-9cf32c7cf795

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 15, 2025

Manufacturers
FDA

Amazon.com Services LLC

DUNS: 128990418

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Petrolatum

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code72288-180
Application NumberM016
Product Classification
M
Marketing Category
C200263
G
Generic Name
Petrolatum
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 15, 2025
FDA Product Classification

INGREDIENTS (7)

MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
CERESINInactive
Code: Q1LS2UJO3A
Classification: IACT
LANOLIN ALCOHOLSInactive
Code: 884C3FA9HE
Classification: IACT
PANTHENOLInactive
Code: WV9CM0O67Z
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
LEVOMENOLInactive
Code: 24WE03BX2T
Classification: IACT
PETROLATUMActive
Quantity: 410 mg in 1 g
Code: 4T6H12BN9U
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/15/2025

principal dispay panel

amazon basics

baby

healing ointment

Skin Protectant

Pediatrician Tested

NET WT 14 OZ (396 g)

image description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/15/2025

Uses

  • temporarily protects minor: cuts - scrapes - burns
  • temporarily protects and helps relieve chapped or cracked skin and lips
  • helps 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

ADVERSE REACTIONS SECTION

LOINC: 34084-4Updated: 9/15/2025

Adverse reaction

DISTRIBUTED BY:

Amazon.com Services LLC

Seattle, WA 98109

1-877-485-0385

amazon

© 2025 Amazon Basics Services LLC, or its affiliates.

All rights reserved.

www.amazon.com/amazonbasics

PLASTIC JAR

how2recycle.info

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/15/2025

Active ingredient

Petrolatum 41%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/15/2025

Purpose

Skin protectant

WARNINGS SECTION

LOINC: 34071-1Updated: 9/15/2025

Warnings

For external use only

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 9/15/2025

Do not use on

  • deep or puncture wounds
  • animal bites
  • serious burns

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 9/15/2025

When using this product

do not get into eyes

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 9/15/2025

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 9/15/2025

Keep out of the reach of children.

If swallowed, get medical help or contact a Poison control Center right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/15/2025

Directions

  • apply as needed
  • for diaper rash, change wet and soiled diapers promptly
  • cleanse the diaper area
  • 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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/15/2025

Inactive ingredients

mineral oil, ceresin, lanolin alcohol, panthenol, glycerin, bisabolol

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 9/15/2025

Claims

Quality products for the little ones you love.

Specially formulated for effective diaper rash care.

Helps heal, soothe, and prevent diaper rash.

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