FDA.reportPublic FDA data

Zinc Oxide and Menthol

Manufacturer
Akron Formulations India Private Limited
Effective date
2026-02-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:46:57

Label at a glance#

ProductZinc Oxide and Menthol
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 ingredientscalamine, chlorothymol, glycerin, lanoline,phenol, sodium bicarbonate, and thymol,white petrolatum

Questions or Comments?Call toll-free +91 9708777888

Manufactured By:

Akron Formulations India Private Limited

134B, Block-B, Bollaram, Jinnaram Mandal, Medak,

Hyderabad, Telangana 502325, India (IND)

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 OintmentPSN1
2123045menthol 0.0044 MG/MG / zinc oxide 0.206 MG/MG Topical OintmentSCD1
2123045Menthol 0.0044 MG/MG / ZNO 0.206 MG/MG Topical OintmentSY1
2123045menthol 0.44 % / zinc oxide 20.6 % Topical OintmentSY1

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87455-0001-1Zinc Oxide and Menthol113 g in 1 TUBEOINTMENT1131

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87455-000187455-0001-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
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
Zinc Oxide and MentholZINC OXIDE, MENTHOLAkron Formulations India Private Limited4b84556c-521f-eebd-e063-6394a90a8e1e2026-02-23WarningsExact identifier
ndc (package): 87455-0001-1
ndc (product): 87455-0001
ndc11 (package): 87455000101
spl id: 4b845517-657b-fec4-e063-6294a90afe6e
spl set id: 4b84556c-521f-eebd-e063-6394a90a8e1e

Reported adverse events (FAERS/openFDA)#

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