BIOELEMENTS AMINO MASK- sulfur cream

Bioelements by

Drug Labeling and Warnings

Bioelements by is a Otc medication manufactured, distributed, or labeled by Bioelements, Neutraderm, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients        Purpose

Sulfur 5%                   Acne treatment

Uses

For the management of acne

Helps prevent acne pimples (and/or acne blemishes, blackheads, whiteheads)

Keep out of reach of children

Stop use and ask a doctor

If skin irritation occurs or gets worse

Do not get into eyes

Warnings

For external use only

When using this product:

Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs only use one topical medication at a time.

Apply only to areas with acne

Do not use on:

- Broken Skin

- Large areas of the skin

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

Directions

Cleanse the Skin thoroughly before applying this product. Cover the entire affected area with a thin layer and let dry 15 minutes then rinse well. Use twice a week. Because excessive drying of the skin may occur, start with one application, then gradually increase to two times a week if needed or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application or discontinue use.

Inactive ingredients
Water (Aqua) (Eau), Kaolin, Caprylic/Capric Triglyceride, Glycerin, Cetearyl Alcohol, Ceteareth-20, Glyceryl Stearate, PEG-100 Stearate, Dipotassium Glycyrrhizate, Lactic Acid, Bentonite, Chondrus Crispus (Carrageenan), Titanium Dioxide (CI 77891), Lavendula Angustifolia (Lavender) Oil, Camellia Sinensis (Green Tea) Leaf Extract, Vitis Vinifera (Grape) Fruit Extract, Actinidia Chinensis (Kiwi) Extract, Mel (Honey) Extract (Miel Extrait de Mile), Niacinamide,  Biotin, Panthenol, Allantoin, Pyroxidine HCL, Hydrolyzed Soy Protein, Phenoxyethanol, Ethylhexylglycerin.

PRINCIPAL DISPLAY PANEL

Bioelements

Amino Mask (R)

Sulfur Acne Treatment Mask with Lactic Acid

73 mL / 2.5 Fl. Oz.

INGREDIENTS AND APPEARANCE

BIOELEMENTS  AMINO MASK
sulfur cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49825-123
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	5 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
KAOLIN (UNII: 24H4NWX5CO)
CAPRYLIC/CAPRIC ACID (UNII: DI775RT244)
GLYCERIN (UNII: PDC6A3C0OX)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
LACTIC ACID (UNII: 33X04XA5AT)
BENTONITE (UNII: A3N5ZCN45C)
CHONDRUS CRISPUS (UNII: OQS23HUA1X)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
LAVENDER OIL (UNII: ZBP1YXW0H8)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
WINE GRAPE (UNII: 3GOV20705G)
KIWI FRUIT (UNII: 71ES77LGJC)
HONEY (UNII: Y9H1V576FH)
NIACINAMIDE (UNII: 25X51I8RD4)
BIOTIN (UNII: 6SO6U10H04)
PANTHENOL (UNII: WV9CM0O67Z)
ALLANTOIN (UNII: 344S277G0Z)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49825-123-02	1 in 1 BOX
1	NDC: 49825-123-01	73 mL in 1 JAR
2	NDC: 49825-123-04	1 in 1 BOX
2	NDC: 49825-123-03	118 mL in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	04/26/2012

Labeler - Bioelements (174813923)

Registrant - Bioelements (174813923)

Establishment
Name	Address	ID/FEI	Business Operations
Neutraderm, Inc.		146224444	manufacture