MedPath

Kidgets Baby Petroleum Jelly

Kidgets Vitamin A & D

Approved
Approval ID

3cf37fa7-6be4-b835-e063-6394a90ad406

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 22, 2025

Manufacturers
FDA

MY IMPORTS USA LLC

DUNS: 195767988

Products 1

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

Lanolin, Petrolatum

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code51628-4248
Application NumberM016
Product Classification
M
Marketing Category
C200263
G
Generic Name
Lanolin, Petrolatum
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 22, 2025
FDA Product Classification

INGREDIENTS (6)

PARAFFINInactive
Code: I9O0E3H2ZE
Classification: IACT
MICROCRYSTALLINE WAXInactive
Code: XOF597Q3KY
Classification: IACT
COD LIVER OILInactive
Code: BBL281NWFG
Classification: IACT
LIGHT MINERAL OILInactive
Code: N6K5787QVP
Classification: IACT
PETROLATUMActive
Quantity: 53.4 g in 100 g
Code: 4T6H12BN9U
Classification: ACTIB
LANOLINActive
Quantity: 15.5 g in 100 g
Code: 7EV65EAW6H
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 1/12/2022

Package Label

label

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/17/2016

Uses

■ helps treat and prevent diaper rash ■ temporarily protects minor cuts, scrapes and burns ■ temporarily protects and relieve chapped,chafed or cracked skin or lips■ protects chafed skin due to diaper rash and helps seal out wetness

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 5/17/2016

Keep out of reach of children

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/17/2016

Active Ingredient

Lanolin 15.5%

Petrolatum 53.4%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/17/2016

Purpose

Diaper rash ointment

Skin protectant

WARNINGS SECTION

LOINC: 34071-1Updated: 5/17/2016

Warnings

For external use only

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 5/17/2016

When using this product

■ do not get into eyes

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 5/17/2016

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 - DO NOT USE SECTION

LOINC: 50570-1Updated: 5/17/2016

Do not use on

■ deep or puncture wounds ■ animal bites ■ serious burns

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/17/2016

Directions

■ for skin protectant use: ■ apply as needed ■ for diaper rash: ■ change wet and 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

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 5/17/2016

Other information

■ store at 20 to 25C (68-77F) ■ do not use if tube seal under cap is broken, missing or if tube tip is cut prior to opening

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/17/2016

Inactive ingredients

cod liver oil (contains vitamin A and vitamin D), fragrance, light mineral oil, microcrystalline wax, paraffin

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Kidgets Baby Petroleum Jelly - FDA Drug Approval Details