Amino Mask

Amino Mask

Drug Labeling and Warnings

Drug Details

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AMINO MASK BIOELEMENTS- 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 ingredient          Purpose

Sulfur 5%                   Acne treatment

Use

For the treatment of acne

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

When using this product: skin irritation and dryness is more likely to occur if you use another topical medication at the same time. If irritation occurs only use one topical acne medication at a time. Apply only to areas with acne.

Warnings

For external use only

Do not use on: Broken skin, large areas of the skin. Stop use and and ask a doctor: if irritation occurs or gets worse. Do not get into eyes.

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.

Bioelements

Acne Clearing System

Amino Mask

5% sulfur acne treatment mask with lactic acid

Treats acne breakouts and allows skin to heal

73 mL / 2.5 Fl. Oz.

Label

Primary

secondary

AMINO MASK  BIOELEMENTS
sulfur cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 49825-128
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
KAOLIN (UNII: 24H4NWX5CO)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
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: 49825-128-021 in 1 BOX06/14/2013
1NDC: 49825-128-0173 mL in 1 JAR; Type 0: Not a Combination Product
2NDC: 49825-128-041 in 1 BOX06/14/2013
2NDC: 49825-128-03118 mL in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H06/14/2013
Labeler - Bioelements (174813923)
Registrant - Bioelements (174813923)
Establishment
NameAddressID/FEIBusiness Operations
Neutraderm, Inc.146224444manufacture(49825-128)

Revised: 1/2017
 
Bioelements


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