ANDALOU NATURALS BLEMISH VANISHING - salicylic acid gel
Sun Deep Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active Ingredient

Salicylic Acid 2.0%

Purpose

Acne Treatment

Uses

For the treatment of acne

Warnings

For external use only. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash of irritation develops and lasts.

Keep out of reach of children.

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

Directions

AM and PM. After cleansing, massage a small amount of gel onto affected areas.
Avoid direct contact with eyes.

Inactive ingredients

Aloe Barbadensis Juice, Vegetable Glycerin, Ethyl Alcohol, Hamamelis Virginiana (Witch Hazel), Hydroxyethyl Cellulose, Salix Alba (Willow Bark), Spirae Ulmaria (Meadowsweet) and Epilobium Angustifolium (Willow Herb) Extracts, Malus Domestica (Apple), Solar Vitis (Grape) and Vaccinium Myrtillus (Bilberry) Fruit Stem Cell Cultures and BioActive 8 Berry Complex, Magnesium Ascorbyl Phosphate (Vitamin C), Zinc Gluconate, Camellia Sinensis (White Tea) Extract, Ubiquinone (CoQ10), Tocopherol (Vitamin E), Arnica Montana, Lavandula Officinalis (Lavender), Chamomilla Recutita (Chamomile) and Calendula Officinalis Extracts, Cinnamomum Camphora (Camphor), Mentha Piperita (Peppermint) and Thymus Vulgaris (Thyme) Oils

Questions

Call (888) 898-6955 or visit www.Andalou.com

Image of outer package

AndalouBlemishgel.jpg Image of outer package

ANDALOU NATURALS BLEMISH VANISHING
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61684-1810
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Salicylic Acid (Salicylic Acid)	Salicylic Acid	2 mL in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Aloe Vera Leaf
Water
Alcohol
Hamamelis Virginiana Root Bark/Stem Bark
Hydroxyethyl Cellulose (140 MPA.S FOR 5% Aqueous Solution)
Salix Alba Bark
Filipendula Ulmaria Root
Epilobium Angustifolium Flowering Top
Magnesium Ascorbyl Phosphate
Zinc Gluconate
Ubidecarenone
Tocopherol
Arnica Montana
Lavandula Angustifolia Flowering Top
Matricaria Recutita
Calendula Officinalis Flower
Cinnamomum Camphora Leaf
Peppermint Oil
Thyme Oil

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:61684-1810-1	18 mL in 1 BOTTLE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	01/18/2012

Labeler - Sun Deep Inc. (189788201)

Establishment
Name	Address	ID/FEI	Operations
Sun Deep Inc.		189788201	manufacture

Revised: 01/2012 Sun Deep Inc.