FDA.reportPublic FDA data

PHYLA ACNE PHAGE SERUM

Manufacturer
COSMAX USA, CORP
Effective date
2025-12-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:31:04

Label at a glance#

ProductPHYLA ACNE PHAGE SERUM
Active ingredientSALICYLIC ACID
Label structure9 sections

Indications and uses

Uses for the treatment of acne helps clear up acne blemishes and allows skin to heal

Dosage and administration

Directions clean the skin thoroughly before applying 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 three times daily 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#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Salicilic Acid 0.5%

OTC - PURPOSE SECTION

Purpose

Acne Treatment

USES

INDICATIONS & USAGE SECTION

Uses

  • for the treatment of acne
  • helps clear up acne blemishes and allows skin to heal

WARNINGS SECTION

WARNINGS

For external use only

OTC - WHEN USING 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Directions

  • clean the skin thoroughly before applying 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 three times daily or as directed by a doctor
  • if bothersome dryness or peeling occurs, reduce application to once a day or every other day

INACTIVE INGREDIENT SECTION

Inactive ingredients

Water, Glycerin, Butylene Glycol, Hydroxyethylcellulose, C. Acnes Bacteriophage, Sodium Phosphate, Sodium Chloride, Phenoxyethanol, Polydextrose, Sclerotium Gum, Niacinamide, Magnesium Sulfate, Caffeine, Calcium Chloride.

OTHER INFORMATION

OTHER SAFETY INFORMATION

Other information

  • store at room temperature
  • avoid high temperatures
  • protect from freezing
  • keep away from flame, fire and heat

OTC - QUESTIONS SECTION

Questions or comments?

visit phyla.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottlecartoncarton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
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41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
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0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
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56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
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ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68577-230-01PHYLA ACNE PHAGE SERUM1 in 1 CARTONLOTION11
68577-230-01PHYLA ACNE PHAGE SERUM30 mL in 1 BOTTLE, DISPENSINGLOTION301

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68577-23068577-230-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAFFEINE3G6A5W338EIACT
CALCIUM CHLORIDEM4I0D6VV5MIACT
POLYDEXTROSEVH2XOU12IEIACT
GLYCERINPDC6A3C0OXIACT
SALICYLIC ACIDO414PZ4LPZACTIB
SCLEROTIUM GUM2X51AD1X3TIACT
NIACINAMIDE25X51I8RD4IACT
MAGNESIUM SULFATEDE08037SABIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
WATER059QF0KO0RIACT
HYDROXYETHYLCELLULOSET4V6TWG28DIACT
LISTERIA VIRUS P100Y763PU3RG7IACT
SODIUM PHOSPHATESE337SVY37IACT
SODIUM CHLORIDE451W47IQ8XIACT
PHENOXYETHANOLHIE492ZZ3TIACT

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
57c4f8d3-f658-502a-e063-6294a90a80af4781173e-cf97-9836-e063-6394a90a97c82026-07-29WarningsExact identifier
spl set id: 4781173e-cf97-9836-e063-6394a90a97c8

Reported adverse events (FAERS/openFDA)#

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