Amari
FDA Label NDC 49811-001

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pacific Media Direct, Llc for the product Amari (NDC 49811-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding description, inactive ingredient, warnings, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Description

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

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

Warnings

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 Label (Amari1)

Front Of Package Label (Amari1)

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Back Of Package Label (Amari2)

Back Of Package Label (Amari2)

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