MedPath

Petroleum

CVS 566.001/566AA-AB Petroleum Jelly Lavender and Chamomile

Approved
Approval ID

3c064e6b-0287-4cbc-8c08-1f9df7d11695

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 1, 2025

Manufacturers
FDA

CVS Pharmacy

DUNS: 062312574

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 Code59779-566
Application NumberM016
Product Classification
M
Marketing Category
C200263
G
Generic Name
White Petrolatum
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 1, 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: 8/1/2025

Principal Panel Display

CVS Health™

Scented Petroleum Jelly

WHITE PETROLATUM USP SKIN PROTECTNAT

  • Moisturizes & heals dryness
  • Helps protect minor cuts, scrapes & burns
  • Helps treat & prevent diaper rash
  • Paraben/phthalate free†

Lavender & Chamomile

NET WT 13 OZ (368 g)

image descriptionimage description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/1/2025

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: 8/1/2025

ADVERSE REACTION

Distributed by: CVS Pharmacy, Inc

One CVS Drive, Woonsocket, RI 02895

©2018 CVS/Phjarmacy CVS.com

1-800-SHOP-CVS

Made in the U.S.A. with U.S. and foreign components

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 8/1/2025

Claims

PARABEN & PHTHALATE FREE

†Typically this product would not include parabens

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/1/2025

Active ingredient

White petrolatum USP (99.8%)

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/1/2025

Purpose

Skin Protectant

WARNINGS SECTION

LOINC: 34071-1Updated: 8/1/2025

Warnings

For external use only

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 8/1/2025

Do not use on

  • deep or puncture wounds
  • animal bites
  • serious burns

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 8/1/2025

When using this product

  • do not get into eyes

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 8/1/2025

Stop use and ask a doctor if

condition worsens

  • symptoms last longer than 7 days or clear up and occur again within a few days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 8/1/2025

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: 8/1/2025

Directions

apply as needed

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/1/2025

Inactive ingredient

fragrance (lavender, chamomile)

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Petroleum - FDA Drug Approval Details