FDA.reportPublic FDA data

MEDPURA Hydroseptine Ointment Protects, Soothes, Helps Promote Healing

Manufacturer
AKRON PHARMA INC
Effective date
2026-01-19
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:33:54

Label at a glance#

ProductHydroseptine
Active ingredientMENTHOL, ZINC OXIDE
Label structure7 sections

Indications and uses

A moisture barrier that prevents and heals skin irritations from urine diarrhea prespiration fistula drainage feeding tube site leakage wound drainage (peri-wound skin) minor burns cuts scrapes itching

Dosage and administration

Cleanse skin gently with mid skin cleanser. Pat dry or allow to air dry. apply a thin layer of Hydroseptine Ointment to reddened or irritated skin 2-4 times daily, or after each incontinent episode or diaper change to promote comfort and long lasting protection.

Label contents#

Full prescribing information#

Active Ingredients 

OTC - ACTIVE INGREDIENT SECTION

Menthol 0.44%

Zinc Oxide 20.6%

Purpose

OTC - PURPOSE SECTION

Active Ingredients                                        Purpose
Menthol 0.44%...........................External analgesic/anti-itch
Zinc Oxide 20.6%......Skin protectant/anorectal astringent 

Uses

INDICATIONS & USAGE SECTION

  • A moisture barrier that prevents and heals skin irritations from
  • urine
  • diarrhea
  • prespiration
  • fistula drainage
  • feeding tube site leakage
  • wound drainage (peri-wound skin)
  • minor burns
  • cuts
  • scrapes
  • itching

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • not for deep or punctured wounds
  • avoid contact with eyes

Stop use and ask doctor if

OTC - ASK DOCTOR SECTION

  • In case of accidental ingestion contact a physician or Poison Control Center right away
  • if condition worsens or does not improve within 7 days, consult a doctor

Directions

DOSAGE & ADMINISTRATION SECTION

Cleanse skin gently with mid skin cleanser. Pat dry or allow to air dry. apply a thin layer of Hydroseptine Ointment to reddened or irritated skin 2-4 times daily, or after each incontinent episode or diaper change to promote comfort and long lasting protection.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Other informationstore at room temperature 15-30 C (59-86 F)

Inactive ingredients calamine, chlorothymol, glycerin, lanoline,phenol, sodium bicarbonate, and thymol,white petrolatum

Questions or Comments?Call toll-free 1-877-255-6999

Manufactured for:

Akron Pharma, Inc.

Fairfield, NJ 07004

www.akronpharma.com

This product is not manufactured or distributed by Calmoseptine Inc., owner of the registered trademark Calmoseptine.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2123045menthol 0.44 % / zinc oxide 20.6 % Topical OintmentPSN4
2123045menthol 0.0044 MG/MG / zinc oxide 0.206 MG/MG Topical OintmentSCD4
2123045Menthol 0.0044 MG/MG / ZNO 0.206 MG/MG Topical OintmentSY4
2123045menthol 0.44 % / zinc oxide 20.6 % Topical OintmentSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71399-6743-12023-03-26C16284748780-1f386c649-ac9a-0266-e053-dadaa90a7c1aMEDPURA Hydroseptine Ointment Protects, Soothes, Helps Promote Healing
71399-6743-12023-01-30C16284748780-1f386c649-ac9a-0266-e053-dadaa90a7c1aMEDPURA Hydroseptine Ointment Protects, Soothes, Helps Promote Healing

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71399-6743-1Hydroseptine100 g in 1 JAROINTMENT1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71399-6743-1GM - Gram71399-6743f368410f-2fc3-4422-9903-e4a6e186397212021-12-08

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71399-674371399-6743-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
WHITE PETROLATUMB6E5W8RQJ4IACT
FERRIC OXIDE RED1K09F3G675IACT
CHLOROTHYMOLLJ25TI0CVTIACT
GLYCERINPDC6A3C0OXIACT
LANOLIN7EV65EAW6HIACT
PHENOL339NCG44TVIACT
SODIUM BICARBONATE8MDF5V39QOIACT
THYMOL3J50XA376EIACT
MENTHOLL7T10EIP3AACTIB
ZINC OXIDESOI2LOH54ZACTIB

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
HydroseptineZINC OXIDE, MENTHOLAKRON PHARMA INC5359d92e-641e-4076-9d91-18daee58a30e2026-01-19WarningsExact identifier
ndc (package): 71399-6743-1
ndc (product): 71399-6743
ndc11 (package): 71399674301
spl id: 48c4ebc3-6b32-2593-e063-6294a90a27e2
spl set id: 5359d92e-641e-4076-9d91-18daee58a30e

Reported adverse events (FAERS/openFDA)#

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