MedPath

Petroleum

Foster & Thrive 069.001/069AA Petroleum Jelly

Approved
Approval ID

043375b2-e636-4822-9e05-df2327d29986

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 27, 2025

Manufacturers
FDA

Strategic Sourcing Services LLC

DUNS: 116956644

Products 1

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

White Petrolatum

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70677-1235
Application NumberM016
Product Classification
M
Marketing Category
C200263
G
Generic Name
White Petrolatum
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 27, 2025
FDA Product Classification

INGREDIENTS (1)

PETROLATUMActive
Quantity: 1 g in 1 g
Code: 4T6H12BN9U
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/27/2025

Principal display panel

NDC 70677-1235-2

COMPARE TO VASELINE ® ORIGINAL HEALING JELLY ®*

Foster & Thrive™

Petroleum Jelly

100% White Petrolatum

SKIN PROTECTANT

Hypoallergenic

NET WT 13 OZ (368 g)

image descriptionimage description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/27/2025

Use

  • 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

ADVERSE REACTIONS SECTION

LOINC: 34084-4Updated: 5/27/2025

Adverse Reaction

Distributed by: Mckesson Corp., via SSSL

Memphis, TN 38141

Money Back Guarantee

www.fosterandthrive.com

©2023 McKesson Corporation

*This product is not manufactured or distributed by Unilever, distributor of Vaseline ® Original Healing Jelly ®100% White Petroleum Skin Protectant.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/27/2025

Active ingredient

White Petrolatum USP (100%)

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/27/2025

Purpose

Skin Protectant

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 5/27/2025

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/27/2025

Directions

Apply as needed

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/27/2025

Inactive ingredients

None

WARNINGS SECTION

LOINC: 34071-1Updated: 5/27/2025

Warnings

For external use only

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 5/27/2025

Do not use on

  • deep or punture wounds
  • animal bites
  • serious burns

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 5/27/2025

When using this product

  • do not get into eyes

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 5/27/2025

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

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Petroleum - FDA Drug Approval Details