Acne Toner

Manufacturer: Bioelements, Inc. | Cosmetic Enterprises Ltd
Effective date: 2013-06-18
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 22:35:44

Label at a glance#

ProductAcne Toner Biolements

Active ingredientSALICYLIC ACID

Label structure2 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient Purpose

Salicylic Acid 0.5% Acne treatment

OTC - PURPOSE SECTION

Uses

For the treatment of acne

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

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 acne medication at a time.

WARNINGS SECTION

warnings

For external use only

DOSAGE & ADMINISTRATION SECTION

Directions

Use after cleansing, day and night, avoiding eye area. Apply to cotton pad and gently wipe over skin. Do not rinse. If dryness or peeling occurs, reduce usage to once a day.

INACTIVE INGREDIENT SECTION

Inactive ingredients

Water (Aqua, Eau), Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract, SD Alcohol, Pentylene Glycol, Hexylene Glycol, PEG-40 Hydrogenated Castor Oil, Glycerin, Vitis Vinifera (Grape) Fruit Extract, Mel (Honey) Extract (Miel Extrait de mile), Sodium Hydroxide, Ananas Sativus (Pineapple) Fruit Extract, Citrus Medica Limonium (Lemon) Fruit Extract, Citrus Aurantifolia (Lime) Fruit Extract, Lavandula Angustifolia(Lavender) Extract, Citrus Grandis (Grapefruit) Fruit Extract, Citrus Aurantium Dulcis (Orange) Fruit Extract, Actinidia Chinensis (Kiwi) Fruit Extract, Carica Papaya (Papaya) Fruit Extract, Citrus Grandis (Grapefruit) Peel Oil, Canarium Luzonicum Gum Nonvolatiles, Citrus Aurantium Dulcis (Orange) Oil, Caprylic/Capric Triglyceride, Lavandula Hybrida (Lavandin) Oil, Tetrahexyldecyl Ascorbate, Ethylhexylglycerin, Phenoxyethanol.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label

primary

secondary

Biolelements

Acne Clearing System

Acne Toner

0.5% salicylic acid acne treatment

Hydrates, clears and eliminates excess oil

88 mL / 3 Fl Oz

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
248684	salicylic acid 0.5 % Topical Cream	PSN	2
248684	salicylic acid 5 MG/ML Topical Cream	SCD	2
248684	salicylic acid 0.5 % Topical Cream	SY	2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277	Product name	1	20190408

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
49825-130-02	2020-01-31	C162847	48780-1	9d75b9d0-c223-f424-e053-dadaa90a57ce	Acne Toner
49825-130-04	2020-01-31	C162847	48780-1	9d75b9d0-c223-f424-e053-dadaa90a57ce	Acne Toner

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
49825-130-01	Acne TonerBiolements	88 mL in 1 BOTTLE	CREAM	88	2
49825-130-02	Acne TonerBiolements	1 in 1 CARTON	CREAM	1	2
49825-130-03	Acne TonerBiolements	236 mL in 1 BOTTLE	CREAM	236	2
49825-130-04	Acne TonerBiolements	1 in 1 CARTON	CREAM	1	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49825-130	ACNE TONER BIOLEMENTS (SALICYLIC ACID) CREAM [BIOELEMENTS, INC.]	2	Legacy NDC, 4 package rows	20130619_1966e710-fded-4d6b-a9cc-978cd6ace4a5.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
SALICYLIC ACID	ACTIVE INGREDIENT	O414PZ4LPZ	2
SALICYLIC ACID	ACTIVE MOIETY	O414PZ4LPZ	2
ELEMI	INACTIVE INGREDIENT	C13XI009KO	2
ETHYLHEXYLGLYCERIN	INACTIVE INGREDIENT	147D247K3P	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	2
GRAPEFRUIT	INACTIVE INGREDIENT	O82C39RR8C	2
GRAPEFRUIT OIL	INACTIVE INGREDIENT	YR377U58W9	2
HAMAMELIS VIRGINIANA LEAF	INACTIVE INGREDIENT	T07U1161SV	2
HEXYLENE GLYCOL	INACTIVE INGREDIENT	KEH0A3F75J	2
HONEY	INACTIVE INGREDIENT	Y9H1V576FH	2
KIWI FRUIT	INACTIVE INGREDIENT	71ES77LGJC	2
LAVANDIN OIL	INACTIVE INGREDIENT	9RES347CKG	2
LAVANDULA ANGUSTIFOLIA FLOWER	INACTIVE INGREDIENT	19AH1RAF4M	2
LEMON	INACTIVE INGREDIENT	24RS0A988O	2
LIME (CITRUS)	INACTIVE INGREDIENT	8CZS546954	2
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	2
ORANGE	INACTIVE INGREDIENT	5EVU04N5QU	2
ORANGE OIL	INACTIVE INGREDIENT	AKN3KSD11B	2
PAPAYA	INACTIVE INGREDIENT	KU94FIY6JB	2
PENTYLENE GLYCOL	INACTIVE INGREDIENT	50C1307PZG	2
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	2
PINEAPPLE	INACTIVE INGREDIENT	2A88ZO081O	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	2
TETRAHEXYLDECYL ASCORBATE	INACTIVE INGREDIENT	9LBV3F07AZ	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	2
WINE GRAPE	INACTIVE INGREDIENT	3GOV20705G	2

Products#

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

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

Acne Toner Biolements
Salicylic Acid
WATER
HAMAMELIS VIRGINIANA LEAF
PENTYLENE GLYCOL
HEXYLENE GLYCOL
GLYCERIN
WINE GRAPE
HONEY
SODIUM HYDROXIDE
PINEAPPLE
LEMON
LIME (CITRUS)
LAVANDULA ANGUSTIFOLIA FLOWER
GRAPEFRUIT
ORANGE
KIWI FRUIT
PAPAYA
GRAPEFRUIT OIL
ELEMI
ORANGE OIL
MEDIUM-CHAIN TRIGLYCERIDES
LAVANDIN OIL
TETRAHEXYLDECYL ASCORBATE
ETHYLHEXYLGLYCERIN
PHENOXYETHANOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
49825-130	49825-130-01, 49825-130-02, 49825-130-03, 49825-130-04

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
SALICYLIC ACID	O414PZ4LPZ	ACTIB
WATER	059QF0KO0R	IACT
HAMAMELIS VIRGINIANA LEAF	T07U1161SV	IACT
PENTYLENE GLYCOL	50C1307PZG	IACT
HEXYLENE GLYCOL	KEH0A3F75J	IACT
GLYCERIN	PDC6A3C0OX	IACT
WINE GRAPE	3GOV20705G	IACT
HONEY	Y9H1V576FH	IACT
SODIUM HYDROXIDE	55X04QC32I	IACT
PINEAPPLE	2A88ZO081O	IACT
LEMON	24RS0A988O	IACT
LIME (CITRUS)	8CZS546954	IACT
LAVANDULA ANGUSTIFOLIA FLOWER	19AH1RAF4M	IACT
GRAPEFRUIT	O82C39RR8C	IACT
ORANGE	5EVU04N5QU	IACT
KIWI FRUIT	71ES77LGJC	IACT
PAPAYA	KU94FIY6JB	IACT
GRAPEFRUIT OIL	YR377U58W9	IACT
ELEMI	C13XI009KO	IACT
ORANGE OIL	AKN3KSD11B	IACT
MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	IACT
LAVANDIN OIL	9RES347CKG	IACT
TETRAHEXYLDECYL ASCORBATE	9LBV3F07AZ	IACT
ETHYLHEXYLGLYCERIN	147D247K3P	IACT
PHENOXYETHANOL	HIE492ZZ3T	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 5 · 285 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRASPINAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
PINEAPPLE	PINEAPPLE	2A88ZO081O	POWDER, FOR SUSPENSION / ORAL		120 mg	Exact identifier — unii candidate 2 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / AURICULAR (OTIC)	63.64 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION/ DROPS / ORAL		750 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / URETERAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / INTRAPERITONEAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRABURSAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	GEL, METERED / TRANSDERMAL		350 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / IONTOPHORESIS	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	CREAM / TOPICAL		57 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	SPRAY / TOPICAL		540 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRAPLEURAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	LIQUID / TOPICAL	2.5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SPONGE / TOPICAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	CAPSULE, COATED PELLETS / ORAL	0.01 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / INTRAMUSCULAR	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION/ DROPS / AURICULAR (OTIC)	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	POWDER, FOR SUSPENSION / ORAL	3390 mg/5ml		Exact identifier — unii candidate 18 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	FILM / BUCCAL	0.09 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	NA		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / SOFT TISSUE	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, CHEWABLE / ORAL		12 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	MOUTHWASH / BUCCAL	100 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRATUMOR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	GEL / TRANSDERMAL		472 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
PINEAPPLE	PINEAPPLE	2A88ZO081O	CONCENTRATE / ORAL	1 mg/1ml		Exact identifier — unii candidate 2 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	CREAM, AUGMENTED / TOPICAL		6 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	TABLET, ORALLY DISINTEGRATING / ORAL		1 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTABLE, LIPOSOMAL / INTRAVENOUS	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / INTRA-ARTERIAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SYRUP / ORAL	71 mg/5ml		Exact identifier — unii candidate 174 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GUM, CHEWING / BUCCAL		230 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION, EXTENDED RELEASE / ORAL		2000 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	ELIXIR / ORAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SPONGE / TOPICAL	2 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / EPIDURAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, FOR SOLUTION / INTRADISCAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, FOR SOLUTION / INTRATHECAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	FILM, SOLUBLE / BUCCAL		5 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / EXTRACORPOREAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	AEROSOL, FOAM / TOPICAL		21 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / PARENTERAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE, LIQUID FILLED / ORAL		185 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / INTRAMUSCULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / INTRACAUDAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	TABLET / ORAL		2 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	LIQUID / INTRAVENOUS	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION/ DROPS / OPHTHALMIC	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE, COATED / ORAL	14.21 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / OPHTHALMIC	6 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SUSPENSION / INTRALESIONAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CLOTH / TOPICAL	0.05 mg/mg		Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	EMULSION / ORAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	136.55 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	78.36 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	FILM, EXTENDED RELEASE / TRANSDERMAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION/ DROPS / AURICULAR (OTIC)		25 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / NASAL	25 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, EMULSION / INTRAVENOUS		24100 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CREAM / TOPICAL		1720 mg	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
e1a609b0-d5e6-40e9-9021-efa39188bb5b			1966e710-fded-4d6b-a9cc-978cd6ace4a5	2013-06-18	Warnings	Exact identifier spl id: e1a609b0-d5e6-40e9-9021-efa39188bb5b spl set id: 1966e710-fded-4d6b-a9cc-978cd6ace4a5

Reported adverse events (FAERS/openFDA)#

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