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Name:Amari
Manufacturer:Pacific Media Direct, Llc
Category:Homeopathic Marketed Drugs


Amari

AMARI  - silicon dioxide and zinc oxide cream 
Pacific Media Direct, LLC

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Amari

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

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.

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Front of Package Label

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Back of Package Label


AMARI 
silicea, zincum oxidatum cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49811-001
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SILICON DIOXIDE (SILICON DIOXIDE) SILICON DIOXIDE .85 g  in 4.25 g
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE .085 g  in 4.25 g
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49811-001-15 4.25 g in 1 PACKET None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 08/31/2008

Labeler - Pacific Media Direct, LLC (843957395)
Registrant - Pacific Media Direct, LLC (843957395)
Establishment
Name Address ID/FEI Operations
Pacific Media Direct, LLC 843957395 relabel
Establishment
Name Address ID/FEI Operations
Gar Laboratories 074933615 manufacture

Revised: 11/2009 Pacific Media Direct, LLC



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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