Bioelements

Manufacturer: Bioelements Inc. | United 1International | Bell International Laboratories
Effective date: 2012-04-18
Label type: HUMAN OTC DRUG LABEL
Version: 16
Source: full-release
Hydrated at: 2026-05-31 22:31:27

Label at a glance#

ProductBioelements Spotless Cleanser

Active ingredientSALICYLIC ACID

Label structure2 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient Purpose

Salicylic Acid 2% Acne treatment gel

OTC - PURPOSE SECTION

-For the treatment of acne

-Dries up acne pimples

-Helps prevent new acne pimples

-Reduces the number of acne pimples

-Penetrates pores to eliminate most acne blemishes

-Helps prevent new acne blemishes, blackheads and whiteheads.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

if swallowed, get medical help or contact poison control center right away

INDICATIONS & USAGE SECTION

-For external use only

WARNINGS SECTION

When using this product: using other topical acne medication at the same time or immediately following the use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor. If sensitive to the sun or when increased sun exposure is expected use a sunscreen when using this and other acne products.

DOSAGE & ADMINISTRATION SECTION

-Apply one pump to wet skin and massage over face avoiding eye area

-Use morning and night

-If dryness or peeling occurs, reduce usage to once a day

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Water (Aqua, Eau), Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Betaine, Sodium Lauryl Glucose Carboxylate, Glycerin, Lauryl Glucoside, Sodium Citrate, Ananas Sativus (Pineapple) Fruit Extract, Carica Papaya (Papaya) Fruit Extract, Panthenol, Allantoin, PEG-150 Distearate, Sodium Chloride

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bioelements

Acne Clearing System

Spotless Cleanser

88 mL / 3 Fl. Oz.

image of front label

image of primary label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
562600	salicylic acid 2 % Medicated Liquid Soap	PSN	16
562600	salicylic acid 20 MG/ML Medicated Liquid Soap	SCD	16
562600	salicylic acid 2 % Facial Cleanser Toner	SY	16
562600	salicylic acid 2 % Facial Scrub	SY	16
562600	salicylic acid 2 % Medicated Liquid Soap	SY	16

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
49825-113-02	2020-01-31	C162847	48780-1	9d75b9d0-b152-f424-e053-dadaa90a57ce	Spotless Cleanser
49825-113-04	2020-01-31	C162847	48780-1	9d75b9d0-b152-f424-e053-dadaa90a57ce	Spotless Cleanser

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
49825-113-01	BioelementsSpotless Cleanser	88 mL in 1 BOTTLE	GEL	88	16
49825-113-02	BioelementsSpotless Cleanser	1 in 1 BOX	GEL	1	16
49825-113-03	BioelementsSpotless Cleanser	236 mL in 1 BOTTLE	GEL	236	16
49825-113-04	BioelementsSpotless Cleanser	1 in 1 BOX	GEL	1	16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49825-113	BIOELEMENTS SPOTLESS CLEANSER (SALICYLIC ACID) GEL [BIOELEMENTS INC.]	16	Legacy NDC, 4 package rows	20120419_97d59626-8a37-4e9b-8074-0038b9626308.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
SALICYLIC ACID	ACTIVE INGREDIENT	O414PZ4LPZ	16
SALICYLIC ACID	ACTIVE MOIETY	O414PZ4LPZ	16
ALLANTOIN	INACTIVE INGREDIENT	344S277G0Z	16
COCAMIDOPROPYL BETAINE	INACTIVE INGREDIENT	5OCF3O11KX	16
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	16
LAURYL GLUCOSIDE	INACTIVE INGREDIENT	76LN7P7UCU	16
PANTHENOL	INACTIVE INGREDIENT	WV9CM0O67Z	16
PAPAYA	INACTIVE INGREDIENT	KU94FIY6JB	16
PEG-150 DISTEARATE	INACTIVE INGREDIENT	6F36Q0I0AC	16
PINEAPPLE	INACTIVE INGREDIENT	2A88ZO081O	16
SODIUM C14-16 OLEFIN SULFONATE	INACTIVE INGREDIENT	O9W3D3YF5U	16
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	16
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	16
WATER	INACTIVE INGREDIENT	059QF0KO0R	16

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

Bioelements Spotless Cleanser
Salicylic Acid
WATER
SODIUM C14-16 OLEFIN SULFONATE
COCAMIDOPROPYL BETAINE
GLYCERIN
LAURYL GLUCOSIDE
SODIUM CITRATE
PINEAPPLE
PAPAYA
PANTHENOL
ALLANTOIN
PEG-150 DISTEARATE
SODIUM CHLORIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
49825-113	49825-113-01, 49825-113-02, 49825-113-03, 49825-113-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SALICYLIC ACID	O414PZ4LPZ	ACTIB
WATER	059QF0KO0R	IACT
SODIUM C14-16 OLEFIN SULFONATE	O9W3D3YF5U	IACT
COCAMIDOPROPYL BETAINE	5OCF3O11KX	IACT
GLYCERIN	PDC6A3C0OX	IACT
LAURYL GLUCOSIDE	76LN7P7UCU	IACT
SODIUM CITRATE	1Q73Q2JULR	IACT
PINEAPPLE	2A88ZO081O	IACT
PAPAYA	KU94FIY6JB	IACT
PANTHENOL	WV9CM0O67Z	IACT
ALLANTOIN	344S277G0Z	IACT
PEG-150 DISTEARATE	6F36Q0I0AC	IACT
SODIUM CHLORIDE	451W47IQ8X	IACT

Source Document#

Source XML

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 · 212 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE, LIQUID FILLED / ORAL		185 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	CREAM / TOPICAL	0.4 %w/w		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / NASAL	330 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SUSPENSION / SUBCUTANEOUS	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRAVASCULAR	0.86 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / DENTAL	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	JELLY / VAGINAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / INTRAVENOUS		2916 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / PERIDURAL	8.07 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / INFILTRATION		3535 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, SUSPENSION / SUBCUTANEOUS	1.6 %w/v		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
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET / ORAL		42 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SPONGE / TOPICAL	2 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION / SUBCUTANEOUS		450 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	TABLET, COATED / ORAL	54.7 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION, CONCENTRATE / INTRAMUSCULAR	0.86 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / RECTAL	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / OPHTHALMIC	6 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, EMULSION / INTRAVENOUS	0.62 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		24 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SOLUTION / INTRA-ARTERIAL	1.35 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	JELLY / TOPICAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SHAMPOO / TOPICAL		150 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS		2922 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS	0.68 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	AEROSOL, FOAM / TOPICAL		21 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	CAPSULE / ORAL		6 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
PINEAPPLE	PINEAPPLE	2A88ZO081O	CONCENTRATE / ORAL	1 mg/1ml		Exact identifier — unii candidate 2 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / TOPICAL	0.32 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	CAPSULE, EXTENDED RELEASE / ORAL		41 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	POWDER / TOPICAL	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	PASTE / DENTAL	20 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION/ DROPS / OPHTHALMIC		12 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / SUBCUTANEOUS		1486 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOAP / TOPICAL	0.76 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	DROPS / OPHTHALMIC	0.08 %w/w		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / SUBCUTANEOUS		1486 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION, CONCENTRATE / ORAL	200 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SUSPENSION / INTRA-ARTICULAR		45 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	ELIXIR / ORAL		5621 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / INTRAMUSCULAR	9 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SHAMPOO / TOPICAL	5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SOLUTION / INTRAPLEURAL	226 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / AURICULAR (OTIC)	63.64 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	TABLET, ORALLY DISINTEGRATING / ORAL		10 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION/ DROPS / AURICULAR (OTIC)		3 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRADERMAL	7 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
PINEAPPLE	PINEAPPLE	2A88ZO081O	POWDER, FOR SUSPENSION / ORAL		120 mg	Exact identifier — unii candidate 2 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRA-ARTICULAR		26 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / INTRAOCULAR		320 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	PASTE / ORAL		3822 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	POWDER / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	LIQUID / INTRAVENOUS		6320 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION / AURICULAR (OTIC)	0.05 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS	0.86 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION/ DROPS / TOPICAL	0.23 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRALESIONAL	0.9 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION, CONCENTRATE / INTRAOCULAR	0.86 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
ALLANTOIN	ALLANTOIN	344S277G0Z	GEL / TOPICAL		8 mg	Exact identifier — unii candidate

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
87645f39-f53a-463a-b956-e4172f3ecdb2			97d59626-8a37-4e9b-8074-0038b9626308	2012-04-18	Warnings	Exact identifier spl id: 87645f39-f53a-463a-b956-e4172f3ecdb2 spl set id: 97d59626-8a37-4e9b-8074-0038b9626308

Reported adverse events (FAERS/openFDA)#

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