ALBA BOTANICA ACNEDOTE OIL CONTROL- salicylic acid lotion

Alba Botanica Acnedote Oil Control by

Drug Labeling and Warnings

Alba Botanica Acnedote Oil Control 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 INGREDIENTS

Salicylic Acid 2.0%

INDICATIONS & USAGE

USE

• For the treatment of acne
• Apply to freshly cleansed face morning and evening
  
• For the best results, use after Alba Botanica Natural ACNEdote Deep Clean Astringent

WARNINGS

WARNINGS

For external use only.

Avoid direct contact with eyes. If contact occurs, flush thoroughly with water.

PURPOSE

Acne Treatment

KEEP OUT OF REACH OF CHILDREN

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

INACTIVE INGREDIENT

water, Ethylhexyl Stearate,Cetearyl Alcohol, Glycerin, Cetyl Alcohol, Dimethicone, Cetearyl Olivate, Sorbitan Olivate, Polysorbate 60, Azadirachta Indica Leaf Extract (1), Camellia Sinensis Leaf Extract (1), Carum Petroselinum (Parsley) Extract, Melissa Officinalis Leaf Extract, Salix Alba (Willow) Bark Extract, Urtica Dioica (Nettle) Extract, Citrus Aurantium Bergamia (Bergamot) Fruit Oil (2), Citrus Aurantium Dulcis (Orange) Peel Oil (2), Mentha Piperita (Peppermint) Oil (2), Potassium Hydroxide, Xanthan Gum, Alcohol (1), Benzoic Acid, Dehydroacetic Acid, Phenoxyethanol.

(1) Certified Organic Ingredient; ((2) For scent only

DOSAGE & ADMINISTRATION

Using other topical acne medications at the same time or immediately following the use of this product may increase dryness or irritation of the skin. If this occurs,only one drug should be used unless directed by a doctor.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ALBA BOTANICA ACNEDOTE OIL CONTROL 
salicylic acid lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61995-2062
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
WATER (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITAN OLIVATE (UNII: MDL271E3GR)
POLYSORBATE 60 (UNII: CAL22UVI4M)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
ALCOHOL (UNII: 3K9958V90M)
BENZOIC ACID (UNII: 8SKN0B0MIM)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
XANTHAN GUM (UNII: TTV12P4NEE)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PEPPERMINT OIL (UNII: AV092KU4JH)
ORANGE OIL (UNII: AKN3KSD11B)
BERGAMOT OIL (UNII: 39W1PKE3JI)
URTICA DIOICA LEAF (UNII: X6M0DRN46Q)
WILLOW BARK (UNII: S883J9JDYX)
AZADIRACHTA INDICA LEAF (UNII: HKY915780T)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
PARSLEY (UNII: 58FMD0Q0EV)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61995-2062-2	1 in 1 CARTON	08/06/2015
1		57 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	08/06/2015

Labeler - The Hain Celestial Group, Inc. (117115556)

Registrant - The Hain Celestial Group, Inc. (014334364)

Establishment
Name	Address	ID/FEI	Business Operations
The Hain Celestial Group, Inc.		014334364	manufacture(61995-2062)