MedPath

Advanced Healing

Family Wellness 247.000/247AC Healing Ointment for Dry and Cracked Skin

Approved
Approval ID

7e64a424-afdb-4eb9-b6af-7b8123f1e207

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 27, 2025

Manufacturers
FDA

FAMILY DOLLAR STORES, INC

DUNS: 024472631

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 Code55319-952
Application NumberM016
Product Classification
M
Marketing Category
C200263
G
Generic Name
Petrolatum
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 27, 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: 5/27/2025

Principal display panel

FAMILY Wellness ™

COMPARE TO AUQAPHOR ® HEALING OINTMENT*

ADVANCED HEALING OINTMENT

SKIN PROTECTANT

  • Helps soothe irritated, dry or cracked skin
  • Hypoallergenic and fragrance-free

DERMATOLOGIST TESTED

NET WT 1.75 OZ (50 g)

image description

INDICATIONS & USAGE SECTION

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

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

ADVERSE REACTIONS SECTION

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

Adverse reactions

DISTRIBUTED BY: MIDWOOD BRANDS, LLC

500 VOLVO PKWY, CHESAPEAKE, VA 23320 USA

MADE IN USA WITH US & FOREIGN COMPONENTS

NOT 100% SATISFIED? Return within 30 days to the store of purchase for a refund (with receipt) or exchange.

OTC - ACTIVE INGREDIENT SECTION

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

Active ingredient

Petrolatum 41%

OTC - PURPOSE SECTION

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

Purpose

Skin protectant

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 puncture wounds
  • animal bites
  • serious burns

OTC - WHEN USING SECTION

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

When using this product

  • do not get in 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

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 contract 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

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

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 5/27/2025

Questions?

Call 1-844-636-7687

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 5/27/2025

Disclaimer

*This product is not manufactured or distributed by Beiersdorf Inc., distributor Aquaphor ® Healing Ointment.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Advanced Healing - FDA Drug Approval Details