Bioelements

Manufacturer: Bioelements | Neutraderm, Inc.
Effective date: 2012-04-26
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:31:33

Label at a glance#

ProductBioelements Amino Mask

Active ingredientSULFUR

Label structure2 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients Purpose

Sulfur 5% Acne treatment

OTC - PURPOSE SECTION

Uses

For the management of acne

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

INDICATIONS & USAGE SECTION

Stop use and ask a doctor

If skin irritation occurs or gets worse

Do not get into eyes

WARNINGS SECTION

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.

DOSAGE & ADMINISTRATION SECTION

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 INGREDIENT SECTION

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bioelements

Amino Mask (R)

Sulfur Acne Treatment Mask with Lactic Acid

73 mL / 2.5 Fl. Oz.

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1291231	sulfur 5 % Medicated Liquid Soap	PSN	1
1291231	sulfur 50 MG/ML Medicated Liquid Soap	SCD	1
1291231	sulfur 5 % Treatment Mask	SY	1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
597b1cfd-7b31-5048-62be-ca5cd740da2f	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
49825-123-02	2020-01-31	C162847	48780-1	9d75b9d0-8557-f424-e053-dadaa90a57ce	Amino Mask
49825-123-04	2020-01-31	C162847	48780-1	9d75b9d0-8557-f424-e053-dadaa90a57ce	Amino Mask

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
49825-123-01	BioelementsAmino Mask	73 mL in 1 JAR	CREAM	73	1
49825-123-02	BioelementsAmino Mask	1 in 1 BOX	CREAM	1	1
49825-123-03	BioelementsAmino Mask	118 mL in 1 JAR	CREAM	118	1
49825-123-04	BioelementsAmino Mask	1 in 1 BOX	CREAM	1	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49825-123	BIOELEMENTS AMINO MASK (SULFUR) CREAM [BIOELEMENTS]	1	Legacy NDC, 4 package rows	20120430_c133f1cb-2ebf-4606-89f8-b902ee643d43.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
SULFUR	ACTIVE INGREDIENT	70FD1KFU70	1
SULFUR	ACTIVE MOIETY	70FD1KFU70	1
ALLANTOIN	INACTIVE INGREDIENT	344S277G0Z	1
BENTONITE	INACTIVE INGREDIENT	A3N5ZCN45C	1
BIOTIN	INACTIVE INGREDIENT	6SO6U10H04	1
CAPRYLIC/CAPRIC ACID	INACTIVE INGREDIENT	DI775RT244	1
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	1
CHONDRUS CRISPUS	INACTIVE INGREDIENT	OQS23HUA1X	1
ETHYLHEXYLGLYCERIN	INACTIVE INGREDIENT	147D247K3P	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	1
GLYCYRRHIZINATE DIPOTASSIUM	INACTIVE INGREDIENT	CA2Y0FE3FX	1
GREEN TEA LEAF	INACTIVE INGREDIENT	W2ZU1RY8B0	1
HONEY	INACTIVE INGREDIENT	Y9H1V576FH	1
KAOLIN	INACTIVE INGREDIENT	24H4NWX5CO	1
KIWI FRUIT	INACTIVE INGREDIENT	71ES77LGJC	1
LACTIC ACID	INACTIVE INGREDIENT	33X04XA5AT	1
LAVENDER OIL	INACTIVE INGREDIENT	ZBP1YXW0H8	1
NIACINAMIDE	INACTIVE INGREDIENT	25X51I8RD4	1
PANTHENOL	INACTIVE INGREDIENT	WV9CM0O67Z	1
PEG-100 STEARATE	INACTIVE INGREDIENT	YD01N1999R	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	1
POLYOXYL 20 CETOSTEARYL ETHER	INACTIVE INGREDIENT	YRC528SWUY	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1
WINE GRAPE	INACTIVE INGREDIENT	3GOV20705G	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 26 matching rows.

Bioelements Amino Mask
Sulfur
WATER
KAOLIN
CAPRYLIC/CAPRIC ACID
GLYCERIN
CETOSTEARYL ALCOHOL
POLYOXYL 20 CETOSTEARYL ETHER
GLYCERYL MONOSTEARATE
PEG-100 STEARATE
GLYCYRRHIZINATE DIPOTASSIUM
LACTIC ACID
BENTONITE
CHONDRUS CRISPUS
TITANIUM DIOXIDE
LAVENDER OIL
GREEN TEA LEAF
WINE GRAPE
KIWI FRUIT
HONEY
NIACINAMIDE
BIOTIN
PANTHENOL
ALLANTOIN
PHENOXYETHANOL
ETHYLHEXYLGLYCERIN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
49825-123	49825-123-01, 49825-123-02, 49825-123-03, 49825-123-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SULFUR	70FD1KFU70	ACTIB
WATER	059QF0KO0R	IACT
KAOLIN	24H4NWX5CO	IACT
CAPRYLIC/CAPRIC ACID	DI775RT244	IACT
GLYCERIN	PDC6A3C0OX	IACT
CETOSTEARYL ALCOHOL	2DMT128M1S	IACT
POLYOXYL 20 CETOSTEARYL ETHER	YRC528SWUY	IACT
GLYCERYL MONOSTEARATE	230OU9XXE4	IACT
PEG-100 STEARATE	YD01N1999R	IACT
GLYCYRRHIZINATE DIPOTASSIUM	CA2Y0FE3FX	IACT
LACTIC ACID	33X04XA5AT	IACT
BENTONITE	A3N5ZCN45C	IACT
CHONDRUS CRISPUS	OQS23HUA1X	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
LAVENDER OIL	ZBP1YXW0H8	IACT
GREEN TEA LEAF	W2ZU1RY8B0	IACT
WINE GRAPE	3GOV20705G	IACT
KIWI FRUIT	71ES77LGJC	IACT
HONEY	Y9H1V576FH	IACT
NIACINAMIDE	25X51I8RD4	IACT
BIOTIN	6SO6U10H04	IACT
PANTHENOL	WV9CM0O67Z	IACT
ALLANTOIN	344S277G0Z	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
ETHYLHEXYLGLYCERIN	147D247K3P	IACT

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 211 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	PASTE, DENTIFRICE / DENTAL	0.4 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
BENTONITE	BENTONITE	A3N5ZCN45C	TABLET, COATED / ORAL	1.8 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	FILM, SOLUBLE / ORAL		2 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
LACTIC ACID	LACTIC ACID	33X04XA5AT	SOLUTION / ORAL		192 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, DELAYED RELEASE / ORAL		66 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CREAM / TOPICAL		80 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
ALLANTOIN	ALLANTOIN	344S277G0Z	GEL / TOPICAL		8 mg	Exact identifier — unii candidate
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		23 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
POLYOXYL 20 CETOSTEARYL ETHER	POLYOXYL 20 CETOSTEARYL ETHER	YRC528SWUY	AEROSOL / TOPICAL	5.5 %w/w		Exact identifier — unii candidate 7 equally ranked IID candidates
NIACINAMIDE	NIACINAMIDE	25X51I8RD4	CREAM / TOPICAL	NA		Exact identifier — unii candidate 4 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION, CONCENTRATE / ORAL	200 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	AEROSOL, FOAM / VAGINAL	3 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET / ORAL	33.34 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	LOTION / TOPICAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
KAOLIN	KAOLIN	24H4NWX5CO	TABLET, DELAYED RELEASE / ORAL	18.5 mg		Exact identifier — unii candidate 13 equally ranked IID candidates
PEG-100 STEARATE	PEG-100 MONOSTEARATE	YD01N1999R	CREAM / TOPICAL		552 mg	Exact identifier — unii candidate 3 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	CAPSULE, EXTENDED RELEASE / ORAL	32.4 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SPONGE / TOPICAL	2 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
LACTIC ACID	LACTIC ACID	33X04XA5AT	INJECTION / INTRAVENOUS		2232 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	LOTION / TOPICAL		177 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
BENTONITE	BENTONITE	A3N5ZCN45C	SYSTEM / TRANSDERMAL	9.86 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
POLYOXYL 20 CETOSTEARYL ETHER	POLYOXYL 20 CETOSTEARYL ETHER	YRC528SWUY	SUSPENSION / ORAL		20 mg	Exact identifier — unii candidate 7 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	EMULSION / OPHTHALMIC		3 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, COATED / ORAL		17 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GEL / TRANSDERMAL		500 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SYRUP / ORAL		16734 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SHAMPOO, SUSPENSION / TOPICAL	3 %w/v		Exact identifier — unii candidate 40 equally ranked IID candidates
KAOLIN	KAOLIN	24H4NWX5CO	SYRUP / ORAL	10 mg/1ml		Exact identifier — unii candidate 13 equally ranked IID candidates
LACTIC ACID	LACTIC ACID	33X04XA5AT	LOTION / TOPICAL	5.7 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / ORAL		32400 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET, EXTENDED RELEASE / ORAL		529 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SYSTEM / IONTOPHORESIS	168.1 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SYSTEM / TOPICAL		420 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION / SUBCUTANEOUS		450 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION / INTRAMUSCULAR		450 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	CREAM / VAGINAL		140 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	AEROSOL, FOAM / TOPICAL		21 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, COATED PELLETS / ORAL	4.4 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET / SUBLINGUAL	1.23 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
LACTIC ACID	LACTIC ACID	33X04XA5AT	SOLUTION / TOPICAL	7.22 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GEL / OPHTHALMIC	0.88 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, COATED / ORAL	1 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	LIQUID / TOPICAL	1 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	LOTION / TOPICAL	1 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	DROPS / ORAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
BENTONITE	BENTONITE	A3N5ZCN45C	TABLET / ORAL	355 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CREAM / TOPICAL		1720 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / SUBCUTANEOUS	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	SUPPOSITORY / RECTAL	35 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	EMULSION / ORAL	NA		Exact identifier — unii candidate 21 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	AEROSOL / TOPICAL	1.05 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CLOTH / TOPICAL	0.05 mg/mg		Exact identifier — unii candidate 75 equally ranked IID candidates
POLYOXYL 20 CETOSTEARYL ETHER	POLYOXYL 20 CETOSTEARYL ETHER	YRC528SWUY	AEROSOL, FOAM / TOPICAL		374 mg	Exact identifier — unii candidate 7 equally ranked IID candidates
POLYOXYL 20 CETOSTEARYL ETHER	POLYOXYL 20 CETOSTEARYL ETHER	YRC528SWUY	SPRAY / TOPICAL	2.42 %w/w		Exact identifier — unii candidate 7 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL		36 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	CAPSULE, DELAYED RELEASE / ORAL		15 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, EMULSION / INTRAVENOUS		24100 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	FILM, SOLUBLE / BUCCAL		11 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, SUSPENSION / SUBCUTANEOUS	1.6 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
e77fa75f-9d7f-4749-81e0-9089b3811174			c133f1cb-2ebf-4606-89f8-b902ee643d43	2012-04-26	Warnings	Exact identifier spl id: e77fa75f-9d7f-4749-81e0-9089b3811174 spl set id: c133f1cb-2ebf-4606-89f8-b902ee643d43

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Bioelements

Label at a glance#

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

INDICATIONS & USAGE SECTION

WARNINGS SECTION

DOSAGE & ADMINISTRATION SECTION

INACTIVE INGREDIENT SECTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Related RxNorm Concepts#

DailyMed RxNorm Mappings#

DailyMed Product Concepts#

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

DailyMed Dashboard NDC Coverage#

DailyMed Socrata Ingredients#

Products#

NDC Codes#

Ingredients#

Source Document#

Inactive ingredient matches#

openFDA label cross-check#

Reported adverse events (FAERS/openFDA)#