FDA.reportPublic FDA data

Hydrophor Ointment

Manufacturer
Akron Pharma Inc.
Effective date
2026-08-28
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
daily-update
Hydrated at
2026-09-01 13:02:04

Label at a glance#

ProductHYDROPHOR
Active ingredientPETROLATUM
Label structure10 sections

Indications and uses

temporarily protects minor: cuts scrapes burns temporarily protects and helps relieve chapped or cracked skin and lips helps protects from the drying effects of wind and cold weather

Dosage and administration

Apply as needed.

Storage and handling

Other Information do not use if inner seal is broken or missing Learn more at www.HydrophorUS.com

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient:

Petrolatum 42%

Purpose:

Skin protectant

Uses

OTC - PURPOSE SECTION

temporarily protects minor:

  • cuts
  • scrapes
  • burns

temporarily protects and helps relieve

  • chapped or cracked skin and lips
  • helps protects from the drying effects of wind and cold weather

Warnings

WARNINGS SECTION

For External Use Only.

INDICATIONS & USAGE SECTION

When using this product:

  • do not get into eyes

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

Do not use on

  • deep or puncture wounds
  • animals bites
  • serious burns

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • KEEP OUT OF REACH OF CHILDREN.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply as needed.

Inactive Ingredient

INACTIVE INGREDIENT SECTION

Ceresin Wax, Lanolin, Mineral Oil, Paraffin Wax & Phenoxyethanol.

STORAGE AND HANDLING SECTION

Other Information

  • do not use if inner seal is broken or missing

Learn more at www.HydrophorUS.com

OTC - QUESTIONS SECTION

Questions?

Please Call 1(877) 225-6999

Manufactured for:

Akron Pharma, Inc.
Fairfield, NJ 07004

Manufactured in U.S.A

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1122

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71399-5101-12023-03-26C16284748780-1f386c649-dbd4-0266-e053-dadaa90a7c1aHydrophor Ointment
71399-5101-12023-03-26C16284748780-1f386c649-dbd4-0266-e053-dadaa90a7c1aHydrophor Ointment
71399-5101-22023-03-26C16284748780-1f386c649-dbd4-0266-e053-dadaa90a7c1aHydrophor Ointment
71399-5101-22023-03-26C16284748780-1f386c649-dbd4-0266-e053-dadaa90a7c1aHydrophor Ointment
71399-5101-12023-01-30C16284748780-1f386c649-dbd4-0266-e053-dadaa90a7c1aHydrophor Ointment
71399-5101-12023-01-30C16284748780-1f386c649-dbd4-0266-e053-dadaa90a7c1aHydrophor Ointment
71399-5101-22023-01-30C16284748780-1f386c649-dbd4-0266-e053-dadaa90a7c1aHydrophor Ointment
71399-5101-22023-01-30C16284748780-1f386c649-dbd4-0266-e053-dadaa90a7c1aHydrophor Ointment

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71399-5101-1GM - Gram71399-51018f2068a4-1e37-4de2-85f6-8cdca8b3578012021-03-02
71399-5101-2GM - Gram71399-5101866bb952-bc4a-4934-8cba-f0611cf962ea12021-03-02

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
71399-510171399-5101-1, 71399-5101-2

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
PETROLATUM4T6H12BN9UACTIB
CERESINQ1LS2UJO3AIACT
LANOLIN7EV65EAW6HIACT
MINERAL OILT5L8T28FGPIACT
PARAFFINI9O0E3H2ZEIACT
PHENOXYETHANOLHIE492ZZ3TIACT

Source Document#

Source XML · Source PDF

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
72026-01-19full-release2026-06-01 01:34:43

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
HYDROPHORHYDROPHORAkron Pharma Inc.e6099df7-d418-479a-9d2e-ced523585aed2026-08-28WarningsExact identifier
ndc (package): 71399-5101-1
ndc (package): 71399-5101-2
ndc (product): 71399-5101
ndc11 (package): 71399510101
ndc11 (package): 71399510102
spl id: 5a1c400d-7ec9-66b1-e063-6394a90af18d
spl set id: e6099df7-d418-479a-9d2e-ced523585aed

Reported adverse events (FAERS/openFDA)#

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