FDA.reportPublic FDA data

Byoma Acne Treatment Spot

Manufacturer
Byoma Ltd
Effective date
2025-04-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:00:48

Label at a glance#

ProductByoma Acne Treatment Spot
Active ingredientSALICYLIC ACID
Label structure9 sections

Dosage and administration

Clean the skin thoroughly before applying this product Cover the entire affected area with a thin layer one to three times daily. Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 2%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Use

INDICATIONS & USAGE SECTION

  • for the treatment of acne

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • 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.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • skin irritation occurs or gets worse.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Centre right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Clean the skin thoroughly before applying this product
  • Cover the entire affected area with a thin layer one to three times daily.
  • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.
  • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Other Information

OTHER SAFETY INFORMATION

Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua (Water), Kaolin, Diatomaceous Earth, Cetearyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Ethyl Linoleate, Phenoxyethanol, Propanediol, Kojic Acid, Glycine Soja (Soybean) Oil, Carthamus Tinctorius (Safflower) Seed Oil, Camphor, Benzyl Alcohol, Sodium Stearoyl Glutamate, Sodium Hydroxide, Phytosphingosine, Ceramide NP, Xanthan Gum, Centella Asiatica Leaf Extract, Ethylhexylglycerin, Bakuchiol, Dehydroacetic Acid, Chlorophyllin-Copper Complex, Rutin, Glycerin, Hydroxycinnamic Acid, Maltodextrin, Sodium Benzoate, Potassium Sorbate.

Questions or Comments?

OTC - QUESTIONS SECTION

Contact hello@byoma.com

Product Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1047415salicylic acid 2 % PastePSN2
1047415salicylic acid 0.02 MG/MG PasteSCD2
1047415salicylic acid 2 % PasteSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84821-008-01Byoma Acne Treatment Spot15 mL in 1 TUBEPASTE152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84821-008BYOMA ACNE TREATMENT SPOT (SALICYLIC ACID) PASTE [BYOMA LTD]2Current NDC, 1 package rows20250513_301673da-7202-49cf-e063-6294a90a520e.zip

Products#

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

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84821-00884821-008-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Name, UNII, Kind table
NameUNIIKind
CENTELLA ASIATICA LEAF6810070TYDIACT
SODIUM BENZOATEOJ245FE5EUIACT
DEHYDROACETIC ACID2KAG279R6RIACT
SODIUM COPPER CHLOROPHYLLIN1D276TYV9OIACT
HYDROXYCINNAMIC ACIDIBS9D1EU3JIACT
KAOLIN24H4NWX5COIACT
ETHYL LINOLEATEMJ2YTT4J8MIACT
DIATOMACEOUS EARTH2RF6EJ0M85IACT
GLYCERYL STEARATE230OU9XXE4IACT
BAKUCHIOLOT12HJU3ARIACT
CERAMIDE NP4370DF050BIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
WATER059QF0KO0RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
KOJIC ACID6K23F1TT52IACT
PEG-100 STEARATEYD01N1999RIACT
PROPANEDIOL5965N8W85TIACT
SODIUM HYDROXIDE55X04QC32IIACT
CAMPHOR (NATURAL)N20HL7Q941IACT
RUTIN5G06TVY3R7IACT
BENZYL ALCOHOLLKG8494WBHIACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
SALICYLIC ACIDO414PZ4LPZACTIB
GLYCERINPDC6A3C0OXIACT
PHYTOSPHINGOSINEGIN46U9Q2QIACT
CETEARYL ALCOHOL2DMT128M1SIACT
SOYBEAN OIL241ATL177AIACT
MALTODEXTRIN7CVR7L4A2DIACT
SAFFLOWER OIL65UEH262ISIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
XANTHAN GUMTTV12P4NEEIACT

Source Document#

Source XML

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Byoma Acne Treatment SpotSALICYLIC ACIDByoma Ltd301673da-7202-49cf-e063-6294a90a520e2025-04-23WarningsExact identifier
ndc (package): 84821-008-01
ndc (product): 84821-008
ndc11 (package): 84821000801
spl id: 3373cef7-4a52-a6a4-e063-6394a90ac7e1
spl set id: 301673da-7202-49cf-e063-6294a90a520e

Reported adverse events (FAERS/openFDA)#

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