BIOELEMENTS AMINO MASK- sulfur cream 
Bioelements

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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Amino Mask

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.



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Bioelements

Amino Mask (R)

Sulfur Acne Treatment Mask with Lactic Acid

73 mL / 2.5 Fl. Oz.





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BIOELEMENTS  AMINO MASK
sulfur cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49825-123
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR5 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49825-123-021 in 1 BOX
1NDC:49825-123-0173 mL in 1 JAR
2NDC:49825-123-041 in 1 BOX
2NDC:49825-123-03118 mL in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D04/26/2012
Labeler - Bioelements (174813923)
Registrant - Bioelements (174813923)
Establishment
NameAddressID/FEIBusiness Operations
Neutraderm, Inc.146224444manufacture

Revised: 4/2012
Document Id: e77fa75f-9d7f-4749-81e0-9089b3811174
Set id: c133f1cb-2ebf-4606-89f8-b902ee643d43
Version: 1
Effective Time: 20120426
 
Bioelements