ZINC-OXYDE PLUS

Manufacturer
First Aid Research Corp. | Anicare Pharmaceuticals Pvt. Ltd
Effective date
2022-02-24
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:48:29

Label at a glance#

ProductZINC-OXYDE PLUS
Active ingredientMENTHOL, ZINC OXIDE
Label structure8 sections

Indications and uses

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

Dosage and administration

cleanse skin gently with mild skin cleanser pat dry or allow to air dry apply a thin layer of 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

External analgesic / Anti-itch

Skin protectant / Anorectal astringent

Uses

INDICATIONS & USAGE SECTION

A moisture barrier that prevents and helps heal skin irritation from: • urine • diarrhea • perspiration • fistula damage • 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

OTC - STOP USE SECTION

Stop use and ask a doctor

• if condition worsens or does not improve within 7 days.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of accidental ingestion contact a physician or poison control center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • cleanse skin gently with mild skin cleanser
  • pat dry or allow to air dry
  • apply a thin layer of 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

butylated hydroxytoluene, calamine, cetyl esters, glycerin, glycerol monostearate, lanolin, PEG-40 hydrogenated castor oil, phenol, sodium bicarbonate, thymol, white petrolatum

Questions?

OTC - QUESTIONS SECTION

call 516-783-0274

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

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

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75983-006-572024-01-30C16284748780-1d6a99b39-8537-a426-e053-dadaa90af4c2Zinc Oxide Plus
75983-006-572022-02-24C16284748780-1d6a99b39-8537-a426-e053-dadaa90af4c2Zinc Oxide Plus
75983-006-572022-01-28C16284748780-1d6a99b39-8537-a426-e053-dadaa90af4c2Zinc Oxide Plus

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75983-006-57ZINC-OXYDE PLUS57 g in 1 TUBEOINTMENT573
75983-006-57ZINC-OXYDE PLUS1 in 1 CARTONOINTMENT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75983-006ZINC-OXYDE PLUS (MENTHOL, ZINC OXIDE) OINTMENT [FIRST AID RESEARCH CORP.]3Legacy NDC, 2 package rows20220225_cbd899ca-80da-4a1b-9b32-2148759d9424.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75983-00675983-006-57

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

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
d8c30b8c-dac8-183a-e053-2a95a90a6a54cbd899ca-80da-4a1b-9b32-2148759d94242022-02-24WarningsExact identifier
spl id: d8c30b8c-dac8-183a-e053-2a95a90a6a54
spl set id: cbd899ca-80da-4a1b-9b32-2148759d9424

Reported adverse events (FAERS/openFDA)#

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