ALBA ACNEDOTE INVISIBLE TREATMENT- salicylic acid lotion

Alba Acnedote Invisible Treatment by

Drug Labeling and Warnings

Alba Acnedote Invisible Treatment by is a Otc medication manufactured, distributed, or labeled by The Hain Celestial Group, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Salicylic Acid 2.0%

DOSAGE & ADMINISTRATION

Cleanse face and apply directly to blemishes morning, evening and more frequently if needed.

PURPOSE

Acne Treatment

WARNINGS

For external use only. Using other topical acne medications at the same time or immediately following the use of this product may increase dryness and irritation of the skin. If this occurs, only one drug should be used unless directed by a doctor. Avoid direct contact with eyes. If contact occurs, flush throughly with water.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed get medical help or contact Poison Center right away.

INACTIVE INGREDIENT

Water, ,Glycerin, Alcohol, Aloe Barbadensis Leaf Juice(1), Hamamelis Verginiana (Witch Hazel) Water, Hydroxyethylcellulose, Spiraea Ulmaria Extract, Lens Esculenta (Lentil) Fruit Extract, Arnica Montana (Flower) Extract (1), Camellia Sinensis Leaf Extract (1), Chamomilla Recutita (Matricaria) Flower Extract (1), Calendula Officinalis Flower Extract (1), Lavandula Angustifolia (Lavender) Extract (1), Glycyrrhiza Glabra (Licorice) Rhizome/Root, Salix Alba (Willow) Bark Extract (1),Citrus Aurantium Dulcis (Orange) Peel Oil (2), Citrus Aurantium Bergamia (Bergamot) Oil (2), Mentha Piperita (Peppermint) Oil (2)

(1) Certified Organicf Ingredient; (2) Natural Fragrance

INDICATIONS & USAGE

For the treatment of acne.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ALBA ACNEDOTE INVISIBLE TREATMENT 
salicylic acid lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61995-2764
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
BERGAMOT OIL (UNII: 39W1PKE3JI)
SALIX ALBA BARK (UNII: 205MXS71H7)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ORANGE OIL (UNII: AKN3KSD11B)
ALCOHOL (UNII: 3K9958V90M)
LAVANDULA ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)
CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)
PEPPERMINT OIL (UNII: AV092KU4JH)
HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)
FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6)
LENS CULINARIS FRUIT (UNII: ZYZ076G9JH)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61995-2764-1	1 in 1 CARTON	10/01/2013
1		14 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	10/01/2013

Labeler - The Hain Celestial Group, Inc. (858894996)

Registrant - The Hain Celestial Group, Inc. (858894996)

Establishment
Name	Address	ID/FEI	Business Operations
The Hain Celestial Group, Inc.		858894996	manufacture(61995-2764)