ALBA BOTANICA FAST FIX FOR PIMPLE- sulfur cream

Alba Botanica Fast Fix for Pimple by

Drug Labeling and Warnings

Alba Botanica Fast Fix for Pimple 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

Sulfur 6.0%

DOSAGE & ADMINISTRATION

Using finger, dab tiny amount on blemishand gently tap to cover with thin layer. For more coverage allow to dry and repeat. Use alone, over or under makeup.

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, Isoamyl Laurate, Caprylic/Capric Triglyceride, Titanium Dioxide (CI77891), Glyceryl Stearate SE, Glycyrrhiza Glabra (Licorice) Root Extract, Salix Alba (Willow) Bark Extract (1), Alcohol (1), Alumina, Stearyl Alcohol, Cetyl Alcohol, Citric Acid, Glycerin, Jojoba Ester, Saccharomyces Ferment, Silica, Benzyl Alcohol, Potassium Sorbate, Sodium Benzoate, Iron Oxides (CI77491).

(1) Certified Organicf Ingredient;

INDICATIONS & USAGE

For the treatment of acne.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ALBA BOTANICA FAST FIX FOR PIMPLE 
sulfur cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61995-2796
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
SALIX ALBA BARK (UNII: 205MXS71H7)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SACCHAROMYCES LYSATE (UNII: R85W246Z1C)
BROWN IRON OXIDE (UNII: 1N032N7MFO)
ISOAMYL LAURATE (UNII: M1SLX00M3M)
SORBITOL (UNII: 506T60A25R)
ALCOHOL (UNII: 3K9958V90M)
ALUMINUM OXIDE (UNII: LMI26O6933)
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)
BENZYL ALCOHOL (UNII: LKG8494WBH)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
CETYL ALCOHOL (UNII: 936JST6JCN)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61995-2796-1	30 g in 1 PACKET; Type 0: Not a Combination Product	01/21/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	01/21/2016

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.		117115556	manufacture(61995-2796)