FDA.reportPublic FDA data

Menthol and Zinc Oxide

Manufacturer
GERI-GENTLE CORPORATION
Effective date
2025-01-06
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:51:00

Label at a glance#

ProductMenthol and Zinc Oxide
Active ingredientMENTHOL, ZINC OXIDE
Label structure9 sections

Indications and uses

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

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION


Menthol 0.44% w/w

Zinc Oxide 20.625% w/w

Purpose

OTC - PURPOSE SECTION

Menthol 0.44% w/w…………….……External Analgesic

Zinc Oxide 20.625% w/w………………. Skin Protectant

uses

INDICATIONS & USAGE SECTION

A moisture barrier that prevents and helps heal skin irritations from;

  • urine
  • diarrhea
  • perspiration
  • fistula drainage
  • feeding tube site leakage
  • wound drainage (peri-wound skin)
  • minor burns
  • cuts
  • scrapes
  • itching

Warnings:

WARNINGS SECTION

■For external use only ■Not for deep or puncture wounds ■Avoid contact with 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

Keep Out Of Reach Of Children

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.

Dosage & Administration:

DOSAGE & ADMINISTRATION SECTION

  • Clean skin with mild skin cleanser
  • Pat dry or allow to air dry
  • Apply a thin layer of Calasoothe 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

Calamine, Glycerine, Lanolin, Light Liquid Paraffin, Petrolatum, Thymol, Tocopheryl Acetate

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display and Drug Fact PanelPrincipal Display and Drug Fact Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2123045menthol 0.44 % / zinc oxide 20.6 % Topical OintmentPSN3
2123045menthol 0.0044 MG/MG / zinc oxide 0.206 MG/MG Topical OintmentSCD3
2123045Menthol 0.0044 MG/MG / ZNO 0.206 MG/MG Topical OintmentSY3
2123045menthol 0.44 % / zinc oxide 20.6 % Topical OintmentSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69771-013-232025-01-06C16284748780-11030e365-237a-111a-e063-dadaa90a10e2GG Tender Calm Menthol 0.44% w/w…………….……External Analgesic Zinc Oxide 20.625% w/w………………. Skin Protectant
69771-013-232024-01-30C16284748780-11030e365-237a-111a-e063-dadaa90a10e2GG Tender Calm Menthol 0.44% w/w…………….……External Analgesic Zinc Oxide 20.625% w/w………………. Skin Protectant

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69771-013-23Menthol and Zinc Oxide113 g in 1 TUBEOINTMENT1133

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69771-013MENTHOL AND ZINC OXIDE OINTMENT [GERI-GENTLE CORPORATION]3Current NDC, Legacy NDC, 1 package rows20250108_e673d8bd-2573-9f04-e053-2995a90a172a.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69771-01369771-013-23

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
GLYCERINPDC6A3C0OXIACT
FERRIC OXIDE RED1K09F3G675IACT
LANOLIN7EV65EAW6HIACT
LIGHT MINERAL OILN6K5787QVPIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
THYMOL3J50XA376EIACT
PETROLATUM4T6H12BN9UIACT
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
Menthol and Zinc OxideMENTHOL AND ZINC OXIDEGERI-GENTLE CORPORATIONe673d8bd-2573-9f04-e053-2995a90a172a2025-01-06WarningsExact identifier
ndc (package): 69771-013-23
ndc (product): 69771-013
ndc11 (package): 69771001323
spl id: 2b0e344b-8e5b-2995-e063-6394a90a9cbc
spl set id: e673d8bd-2573-9f04-e053-2995a90a172a

Reported adverse events (FAERS/openFDA)#

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