61010-4405, A and D Ointment

Manufacturer
Safetec of America, Inc.
Effective date
2024-02-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:08:36

Label at a glance#

ProductA and D
Active ingredientPETROLATUM
Label structure9 sections

Dosage and administration

Apply as needed

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

White Petrolatum 76 %

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Use

INDICATIONS & USAGE SECTION

  • Temporarily protects minor:
    • cuts
    • scrapes
    • burns
  • Temporarily protects and helps relieve chafed, chapped, or cracked skin and lips
  • Helps prevent and protect from the drying effects or wind and cold weather

Warnings

WARNINGS SECTION

For external use only.

Do not use on

OTC - DO NOT USE SECTION

  • deep or puncture wounds
  • animal bites
  • serious burns

When using this product:

OTC - WHEN USING SECTION

  • do not get into eyes

Stop use and ask a doctor if:

OTC - STOP USE SECTION

  • 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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

Apply as needed

Other Information

OTHER SAFETY INFORMATION

Store at room temperature

  • Avoid excessive heat

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Lanolin, Lavender Oil, Light Liquid Paraffin, Vitamin A, Vitamin D

Principal Display Panel –Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Safetec®

A&D Ointment

Skin Protectant with Vitamins A & D

Net Wt. 4oz. (113.4g)

Reorder No. 56001

Manufactured for: Safetec of America INC.

Buffalo, NY 14215 | 1-800-456-7077

Made in IndiaKD/739

Principal Display Panel –Tube Label
Principal Display Panel –Tube Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049072petrolatum 76 % Topical OintmentPSN2
1049072petrolatum 0.76 MG/MG Topical OintmentSCD2
1049072petrolatum 76 % Topical OintmentSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61010-4405-12024-02-12C16284748780-11030e365-066e-111a-e063-dadaa90a10e261010-4405, A and D Ointment
61010-4405-12024-01-30C16284748780-11030e365-066e-111a-e063-dadaa90a10e261010-4405, A and D Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61010-4405-1A and D113.4 g in 1 TUBEOINTMENT113.42

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61010-4405A AND D (PETROLATUM) OINTMENT [SAFETEC OF AMERICA, INC.]2Current NDC, Legacy NDC, 1 package rows20240214_b9afda3a-9e1d-46c1-b7aa-c3143caf709e.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61010-440561010-4405-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
A and DPETROLATUMSafetec of America, Inc.b9afda3a-9e1d-46c1-b7aa-c3143caf709e2024-02-09WarningsExact identifier
ndc (package): 61010-4405-1
ndc (product): 61010-4405
ndc11 (package): 61010440501
spl id: 10f4a842-d738-4f34-e063-6294a90a2823
spl set id: b9afda3a-9e1d-46c1-b7aa-c3143caf709e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.