FDA.reportPublic FDA data

Amari

Manufacturer
Pacific Media Direct, LLC | Gar Laboratories
Effective date
2009-11-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:02:57

Label at a glance#

ProductAmari
Active ingredientSILICON DIOXIDE, ZINC OXIDE
Label structure5 sections

Label contents#

Full prescribing information#

DESCRIPTION SECTION

Instructions for use:

1.  Apply Amari Cream to all external genital areas not covered by a condom.

2.  Re-apply Amari Cream before each sexual encounter or every two hours.

3.  Amari Cream only provides external physical protection (not internal) against STD viruses - it doesn't actually kill a virus.

4.  It is always a good idea to shower or bathe after sex to safely wash away any viruses that may present on your skin.

Store at room temperature.  Avoid exposing it to extreme heat.

Reminder: Amari Cream plus a condom is highly effective in protecting against some of the most common STD viruses.

The only way to be completely protected is through abstinence.  See your healthcare provider regularly.

Manufactured For:PMD LLC 9550 S. Eastern Ave. Suite 253

                               Henderson, NV 89123

INACTIVE INGREDIENT SECTION

Inactive Ingredients:  Aloe Vera, Cetearyl Alcohol, Glycerine, Benzylonium Chloride, Purified Water 

WARNINGS SECTION

Warnings:Do not engage in sex if you or your partner has a genital lesion.  For external use only.  Avoid contact with your eyes.  Stop using if any discomfort or itching occurs during or after use of this product.  Keep out of reach of children.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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Front of Package LabelFront of Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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Back of Package LabelBack of Package Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49811-001-152019-10-21C16284748780-1956f9ecf-beb0-621f-e053-dbdaa90a74adAmari

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49811-001-15Amari4.25 g in 1 PACKETCREAM4.252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49811-001AMARI (SILICEA, ZINCUM OXIDATUM) CREAM [PACIFIC MEDIA DIRECT, LLC]2Legacy NDC, 1 package rows20110113_d374bcd9-7614-4252-9ffd-4b0abc8527dd.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SILICON DIOXIDEACTIVE INGREDIENTETJ7Z6XBU42
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z2
SILICON DIOXIDEACTIVE MOIETYETJ7Z6XBU42
ZINC OXIDEACTIVE MOIETYSOI2LOH54Z2

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49811-00149811-001-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
SILICON DIOXIDEETJ7Z6XBU4ACTIB
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
185c655b-7233-4398-948d-f47cd0b18a3dd374bcd9-7614-4252-9ffd-4b0abc8527dd2009-11-16WarningsExact identifier
spl id: 185c655b-7233-4398-948d-f47cd0b18a3d
spl set id: d374bcd9-7614-4252-9ffd-4b0abc8527dd

Reported adverse events (FAERS/openFDA)#

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