FDA.reportPublic FDA data

Healing Ointment

Manufacturer
Neilmed Pharmaceuticals Inc.,
Effective date
2025-12-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:30:59

Label at a glance#

ProductHydrating Healing
Active ingredientPETROLATUM
Label structure15 sections

Indications and uses

Temporarily protects minor cuts, scrapes & burns Temporarily protects and helps relieve chapped or cracked skin/lips Helps protect from the drying effects of wind and cold weather Helps treat and prevent diaper rash Protects chafed skin associated with diaper rash and helps protect from wetness

Dosage and administration

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 any time when exposure to wet diapers may be prolonged.

Storage and handling

Store at a temperature between 15° C and 30° C (59° F to 86° F)

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Petrolatum (41%).....

Purpose

OTC - PURPOSE SECTION

Skin protectant

Uses

INDICATIONS & USAGE SECTION

  • Temporarily protects minor cuts, scrapes & burns
  • Temporarily protects and helps relieve chapped or cracked skin/lips
  • Helps protect from the drying effects of wind and cold weather
  • Helps treat and prevent diaper rash
  • Protects chafed skin associated with diaper rash and helps protect from wetness

Warnings

WARNINGS SECTION

For external use only

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

Do not use on:

OTC - DO NOT USE SECTION

  • deep or puncture wounds
  • animal bites
  • serious burns

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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 any time when exposure to wet diapers may be prolonged.

O​ther information:

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Storage

STORAGE AND HANDLING SECTION

  • Store at a temperature between 15° C and 30° C (59° F to 86° F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

  • Bisabolol
  • Ceresin
  • Glycerin
  • Lanolin alcohol
  • Mineral oil
  • Panthenol

Tamper Evident

OTHER SAFETY INFORMATION

Do not use if seal on tube is punctured or missing

Questions?

OTC - QUESTIONS SECTION

1(877) 477-8633

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TubeTube

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
725145petrolatum 41 % Topical OintmentPSN1
725145petrolatum 0.41 MG/MG Topical OintmentSCD1
725145petrolatum 41 % Topical OintmentSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13709-353-01Hydrating Healing85 g in 1 TUBEOINTMENT851
13709-353-01Hydrating Healing1 in 1 CARTONOINTMENT11

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
13709-35313709-353-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
CERESINQ1LS2UJO3AIACT
GLYCERINPDC6A3C0OXIACT
MINERAL OILT5L8T28FGPIACT
BISABOLOL24WE03BX2TIACT
LANOLIN ALCOHOL884C3FA9HEIACT
PETROLATUM4T6H12BN9UACTIB
PANTHENOLWV9CM0O67ZIACT

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
Hydrating HealingHYDRATING HEALING OINTMENTNeilmed Pharmaceuticals Inc.,47106abb-4c39-07d9-e063-6394a90a4fae2025-12-28WarningsExact identifier
ndc (package): 13709-353-01
ndc (product): 13709-353
ndc11 (package): 13709035301
spl id: 47106abb-4c3a-07d9-e063-6394a90a4fae
spl set id: 47106abb-4c39-07d9-e063-6394a90a4fae

Reported adverse events (FAERS/openFDA)#

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