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Lanolin, Petrolatum

Rite Aid 013.000/013AA-AB Vitamin A&D Ointment

Approved
Approval ID

1b6d7cdf-e7bc-4fd4-939c-5eb0eaa1744d

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jun 23, 2025

Manufacturers
FDA

Rite Aid

DUNS: 014578892

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 Code11822-0103
Application NumberM016
Product Classification
M
Marketing Category
C200263
G
Generic Name
Lanolin, Petrolatum
Product Specifications
Route of AdministrationTOPICAL
Effective DateJune 23, 2025
FDA Product Classification

INGREDIENTS (6)

COD LIVER OILInactive
Code: BBL281NWFG
Classification: IACT
LIGHT MINERAL OILInactive
Code: N6K5787QVP
Classification: IACT
MICROCRYSTALLINE WAXInactive
Code: XOF597Q3KY
Classification: IACT
PARAFFINInactive
Code: I9O0E3H2ZE
Classification: IACT
LANOLINActive
Quantity: 155 mg in 1 g
Code: 7EV65EAW6H
Classification: ACTIB
PETROLATUMActive
Quantity: 534 mg in 1 g
Code: 4T6H12BN9U
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 6/23/2025

principal display panel

FREE FROM

PARABEN FREE†

PHTHALATE FREE

NDC 11822-0103-4

VITAMINS A & D

DIAPER RASH OINTMENT

SKIN PROTECTANT

Seals out wetness

Helps heal dry, flaky chafed skin

Hypoallergenic

Compare to the ingredicants in A+D ®Original Ointment*

NET WT 4 oz (113 g)

image description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 6/23/2025

Uses

  • helps treat and prevent diaper rash
  • temporarily protects minor: cuts - scrapes - burns
  • temporarily protects and helps relieve chafed, chapped or cracked skin and lips
  • helps protect from the drying effects of wind and cold weather

ADVERSE REACTIONS SECTION

LOINC: 34084-4Updated: 6/23/2025

Adverse Reaction

DISTRIBUTED BY:

RITE AID, 30 HUNTER LANE,

CAMP HILL, PA 17011

www.riteaid.com

SATISFACTION GUARANTEE

If you're not satisfied, we'll happily refund your money.

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 6/23/2025

Do not use on

  • deep or puncture wounds
  • animal bites
  • serious burns

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 6/23/2025

When using this product

  • do not get into eyes

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 6/23/2025

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: 6/23/2025

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: 6/23/2025

Active ingredients

Lanolin 15.5%

Petrolatum 53.4%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 6/23/2025

Purpose

Skin protectant

WARNINGS SECTION

LOINC: 34071-1Updated: 6/23/2025

Warnings

For external use only

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 6/23/2025

Directions

***for skin protectant use:**apply as needed *for diaper rash use:

  • change wet or 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

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 6/23/2025

Disclaimer

*This product is not manufactured or distributed by Bayer HealthCare LLC, distributer of A+D ®Original Ointment.

Typically this product would not include patabens.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 6/23/2025

Inactive ingredients

cod liver oil (contains vitamins A+D), fragrance, light mineral oil, microcrystalline wax, paraffin

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Lanolin, Petrolatum - FDA Drug Approval Details