AMARI- silicea, zincum oxidatum cream

Amari by

Drug Labeling and Warnings

Amari by is a Homeopathic medication manufactured, distributed, or labeled by Pacific Media Direct, LLC, Gar Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

PRINCIPAL DISPLAY PANEL

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PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

AMARI 
silicea, zincum oxidatum cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49811-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	.85 g  in 4.25 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	.085 g  in 4.25 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49811-001-15	4.25 g in 1 PACKET

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	Business Operations
Pacific Media Direct, LLC		843957395	relabel

Establishment
Name	Address	ID/FEI	Business Operations
Gar Laboratories		074933615	manufacture