FDA.reportPublic FDA data

Ammens Medicated Powder Original

Manufacturer
Idelle Labs, Ltd | PTI Union, LLC | M.K. Packaging, Inc.
Effective date
2013-05-14
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 22:35:27

Label at a glance#

ProductAmmens Medicated Powder Original
Active ingredientZINC OXIDE
Label structure13 sections

Indications and uses

Dries the oozing and weeping of poison ivy oak sumac

Dosage and administration

Apply as needed.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Medicated Powder
Ammens
Original Medicated Formula

All-Day Protection

  • soothes
  • deodorant protection
  • relieves chafing
  • cools


Active Ingredient Zinc Oxide 9.1%

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 9.1%

Purpose:

OTC - PURPOSE SECTION

Skin protectant powder


Uses:

INDICATIONS & USAGE SECTION

Dries the oozing and weeping of poison

  • ivy
  • oak
  • sumac

Warning:

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

do not get into 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

If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

Apply as needed.

Other Information:

OTHER SAFETY INFORMATION

  • Do not use on broken skin.
  • When using this product, keep away from face and mouth to avoid breathing it in.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Corn starch, fragrance, 8-hydroxyquinoline, 8-hydroxyquinoline sulfate, isostearic acid, PPG-20 methyl glucose ether, talc.

Questions or comments?

OTC - QUESTIONS SECTION

1-800-487-7273

©2011 Idelle Labs, Ltd. All rights reserved
Made in the USA and distributed by Idelle Labs, Ltd., El Paso, TX 79912

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label
label

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
41595-1058-12020-01-31C16284748780-19d75b9d0-dfff-f424-e053-dadaa90a57ceAmmens Medicated Powder
41595-1058-22020-01-31C16284748780-19d75b9d0-dfff-f424-e053-dadaa90a57ceAmmens Medicated Powder

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41595-1058-1Ammens Medicated Powder Original177 g in 1 CANISTERPOWDER1774
41595-1058-2Ammens Medicated Powder Original312 g in 1 CANISTERPOWDER3124

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41595-1058AMMENS MEDICATED POWDER ORIGINAL (ZINC OXIDE) POWDER [IDELLE LABS, LTD]4Legacy NDC, 2 package rows20130520_8e264662-b5c8-4e64-a02b-c4f3e01564fb.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z4
ZINC CATIONACTIVE MOIETY13S1S8SF374
ISOSTEARIC ACIDINACTIVE INGREDIENTX33R8U00624
OXYQUINOLINEINACTIVE INGREDIENT5UTX5635HP4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJ4
TALCINACTIVE INGREDIENT7SEV7J4R1U4

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
41595-105841595-1058-1, 41595-1058-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIM
STARCH, CORNO8232NY3SJIACT
OXYQUINOLINE5UTX5635HPIACT
ISOSTEARIC ACIDX33R8U0062IACT
TALC7SEV7J4R1UIACT

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 60 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
TALCTALC7SEV7J4R1UGRANULE / ORAL322 mgExact identifier — unii candidate
35 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJPOWDER, FOR SUSPENSION / ORAL34 mgExact identifier — unii candidate
22 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, COATED / ORAL256 mgExact identifier — unii candidate
22 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJCONCENTRATE / ORALNAExact identifier — unii candidate
22 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJCAPSULE, COATED, EXTENDED RELEASE / ORAL19 mgExact identifier — unii candidate
22 equally ranked IID candidates
TALCTALC7SEV7J4R1UCAPSULE, COATED, EXTENDED RELEASE / ORAL20 mgExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, ORALLY DISINTEGRATING / ORAL80 mgExact identifier — unii candidate
35 equally ranked IID candidates
ISOSTEARIC ACIDISOSTEARIC ACIDX33R8U0062GEL / TOPICAL20 mgExact identifier — unii candidate
3 equally ranked IID candidates
TALCTALC7SEV7J4R1UPELLET / ORAL69 mgExact identifier — unii candidate
35 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJCAPSULE, DELAYED RELEASE / ORAL216 mgExact identifier — unii candidate
22 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, DELAYED RELEASE PARTICLES / ORAL56 mgExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UOINTMENT / TOPICAL74.6 %w/wExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, FILM COATED / ORAL91 mgExact identifier — unii candidate
35 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJINSERT / VAGINAL147 mgExact identifier — unii candidate
22 equally ranked IID candidates
TALCTALC7SEV7J4R1ULOZENGE / ORAL50 mgExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, DELAYED RELEASE / ORAL349 mgExact identifier — unii candidate
35 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, DELAYED RELEASE / ORAL713 mgExact identifier — unii candidate
22 equally ranked IID candidates
TALCTALC7SEV7J4R1UELIXIR / ORAL4.5 mg/5mlExact identifier — unii candidate
35 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, FILM COATED / ORAL2000 mgExact identifier — unii candidate
22 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, FOR SUSPENSION / ORAL24 mgExact identifier — unii candidate
35 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, ORALLY DISINTEGRATING / ORAL100 mgExact identifier — unii candidate
22 equally ranked IID candidates
TALCTALC7SEV7J4R1UCAPSULE, COATED / ORAL87 mgExact identifier — unii candidate
35 equally ranked IID candidates
ISOSTEARIC ACIDISOSTEARIC ACIDX33R8U0062OINTMENT / TOPICALNAExact identifier — unii candidate
3 equally ranked IID candidates
TALCTALC7SEV7J4R1USUSPENSION / ORAL234 mgExact identifier — unii candidate
35 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJSUSPENSION, EXTENDED RELEASE / ORAL113 mgExact identifier — unii candidate
22 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJDROPS / ORALNAExact identifier — unii candidate
22 equally ranked IID candidates
TALCTALC7SEV7J4R1UCAPSULE, EXTENDED RELEASE / ORAL5119 mgExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UCAPSULE / ORAL729 mgExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UCAPSULE, COATED PELLETS / ORAL14 mgExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UGRANULE, FOR SUSPENSION / ORAL296 mgExact identifier — unii candidate
35 equally ranked IID candidates
ISOSTEARIC ACIDISOSTEARIC ACIDX33R8U0062CREAM / TOPICAL100 mgExact identifier — unii candidate
3 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, EXTENDED RELEASE / ORAL184 mgExact identifier — unii candidate
22 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET / ORAL1000 mgExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, EXTENDED RELEASE / ORAL300 mgExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET / BUCCAL15 mgExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UGRANULE, DELAYED RELEASE / ORAL525 mgExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, CHEWABLE, EXTENDED RELEASE / ORAL18 mgExact identifier — unii candidate
35 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET / BUCCAL16.6 mgExact identifier — unii candidate
22 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL357 mgExact identifier — unii candidate
35 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET / ORAL1116 mgExact identifier — unii candidate
22 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET / SUBLINGUAL409 mgExact identifier — unii candidate
22 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, CHEWABLE / ORAL180 mgExact identifier — unii candidate
22 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL21 mgExact identifier — unii candidate
22 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJCAPSULE, EXTENDED RELEASE / ORAL194 mgExact identifier — unii candidate
22 equally ranked IID candidates
TALCTALC7SEV7J4R1USUSPENSION, EXTENDED RELEASE / ORAL46 mgExact identifier — unii candidate
35 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJSUSPENSION / ORAL900 mgExact identifier — unii candidate
22 equally ranked IID candidates
TALCTALC7SEV7J4R1UCAPSULE, DELAYED RELEASE / ORAL420 mgExact identifier — unii candidate
35 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJPASTILLE / ORALNAExact identifier — unii candidate
22 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, FILM COATED, EXTENDED RELEASE / ORAL60 mgExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UPOWDER, FOR SUSPENSION / ORAL735 mgExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UPOWDER / TOPICAL9235 mgExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UGUM, CHEWING / BUCCALNAExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET / RECTAL32.4 mgExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UDROPS / ORALNAExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET / SUBLINGUAL32.4 mgExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, COATED / ORAL320.75 mgExact identifier — unii candidate
35 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJSUSPENSION/ DROPS / ORAL90 mgExact identifier — unii candidate
22 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, CHEWABLE / ORAL202 mgExact identifier — unii candidate
35 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJCAPSULE / ORAL5785 mgExact identifier — unii candidate
22 equally ranked IID candidates

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
6ec59bf1-1ccd-4428-a013-f42954521a9e8e264662-b5c8-4e64-a02b-c4f3e01564fb2013-05-14WarningsExact identifier
spl id: 6ec59bf1-1ccd-4428-a013-f42954521a9e
spl set id: 8e264662-b5c8-4e64-a02b-c4f3e01564fb

Reported adverse events (FAERS/openFDA)#

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