Label: AMINO MASK BIOELEMENTS- sulfur cream
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- NDC Code(s): 49825-128-01, 49825-128-02, 49825-128-03, 49825-128-04
- Packager: Bioelements
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated November 23, 2019
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ACTIVE INGREDIENT
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. - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
AMINO MASK BIOELEMENTS
sulfur creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49825-128 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 5 g in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:49825-128-02 1 in 1 BOX 06/14/2013 1 NDC:49825-128-01 73 mL in 1 JAR; Type 0: Not a Combination Product 2 NDC:49825-128-04 1 in 1 BOX 06/14/2013 2 NDC:49825-128-03 118 mL in 1 JAR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 06/14/2013 Labeler - Bioelements (174813923) Registrant - Bioelements (174813923) Establishment Name Address ID/FEI Business Operations Neutraderm, Inc. 146224444 manufacture(49825-128)
