FDA.reportPublic FDA data

BlemFree

Manufacturer
Equibal, Inc.
Effective date
2025-12-17
Label type
HUMAN OTC DRUG LABEL
Version
15
Source
full-release
Hydrated at
2026-06-01 01:26:37

Label at a glance#

ProductBlemFree
Active ingredientSALICYLIC ACID
Label structure12 sections

Indications and uses

Acne

Dosage and administration

After using Blemfree™ Cleansing WashConcentrate and Toner & Balancer in the morning, smooth a thin layer of Blemfree™ All-Day Lotion on your face, neck, or back. Start with one application daily, then increase to two times daily if needed or as  directed by a doctor.

Label contents#

Full prescribing information#

Drug Facts Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 0.5% w/w

Purpose

OTC - PURPOSE SECTION

Management of Acne

Keep out of reach of children.

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.

Uses

INDICATIONS & USAGE SECTION

Acne

Warnings

WARNINGS SECTION

For external use only

Ask a doctor if

OTC - ASK DOCTOR SECTION

pregnant or breastfeeding

When using this product do not get into eyes.

OTC - WHEN USING SECTION

if contact occurs, rinse eyes thoroughly with water

Stop use and ask a doctor if

OTC - STOP USE SECTION

irritation and redness become severe

Do not use in conjunction

OTHER SAFETY INFORMATION

conjunctionwith other products containing acids or Benzoyl Peroxide. Do use harsh cleaning pads or brushes.

Directions

DOSAGE & ADMINISTRATION SECTION

After using Blemfree™ Cleansing WashConcentrate and Toner & Balancer in the morning, smooth a thin layer of Blemfree™ All-Day Lotion on your face, neck, or back. Start with one application daily, then increase to two times daily if needed or as  directed by a doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Behentrimonium Methosulfate, Benzethonium Chloride, Bisabolol, Butylene Glycol, Cetyl Alcohol, Chamomilla (Metricarla Recutia) Extract, Chlorhexidine Gluconate, Dimethicone, Mentha Spicata (Spearmint) Oil, Menthyl Lactate, Octyldodecanol, Phenoxyethanol, Polyquatemium-37, Rosemary (Rosmarinus Officinalis) Leaf Oil, Stearic Acid, Water (Aqua), Witch Hazel (Hamamelis Virginiana) Extract.

BlemFree Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BLEMFREE.COM

EQUIBAL LABS, INC. ●1 (800) 247-2405

PATENT# 7,078,050

4 OZ. 118ML

Blemfree ™

A NATURAL APPROACH TO FIGHT ACNE

This patented antibacterial lotion protects our skin all while fighting bacteria. The astringent formula breaks down excess oils without causing redness or excessive dryness.

DRUG FACTSUse(s): Management of acne

Active Ingredient                     Purpose

Salicylic Acid 0.5% w/w     Management of Acne

Warnings: For external use only.

Do not use more than one acne product at a time.

Ask doctor ifpregnant or breastfeeding

When using product do not get into eyes.

If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor ifirritation and redness become severe.

Do not use in conjunctionwith other products containing acids or Benzoyl Peroxide. Do use harsh cleaning pads or brushes.

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

Inactive Ingredients:Behentrimonium Methosulfate, Benzethonium Chloride, Bisabolol, Butylene Glycol, Cetyl Alcohol, Chamomilla (Metricarla Recutia) Extract, Chlorhexidine Gluconate, Dimethicone, Mentha Spicata (Spearmint) Oil, Menthyl Lactate, Octyldodecanol, Phenoxyethanol, Polyquatemium-37, Rosemary (Rosmarinus Officinalis) Leaf Oil, Stearic Acid, Water (Aqua), Witch Hazel (Hamamelis Virginiana) Extract.

Directions:After using Blemfree™ Cleansing WashConcentrate and Toner & Balancer in the morning, smooth a thin layer of Blemfree™ All-Day Lotion on your face, neck, or back. Start with one application daily, then increase to two times daily if needed or as  directed by a doctor.

Blemfree™ ALL DAY LOTION        VISIT BLEMFREE.COM

                                                                For an explanation of our ingredients.

DRUG FACTS                     Use(s): Management of acne

Active Ingredient                 Purpose

Salicylic Acid 0.5% w/w                Management of Acne

Warnings: For external use only.

Do not use more than one acne product at a time.

Ask doctor ifpregnant or breastfeeding

When using product do not get into eyes.

If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor ifirritation and redness become severe.

Do not use in conjunctionwith other products containing acids or Benzoyl Peroxide. Do use harsh cleaning pads or brushes.

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

Inactive Ingredients:Behentrimonium Methosulfate, Benzethonium Chloride, Bisabolol, Butylene Glycol, Cetyl Alcohol, Chamomilla (Metricarla Recutia) Extract, Chlorhexidine Gluconate, Dimethicone, Mentha Spicata (Spearmint) Oil, Menthyl Lactate, Octyldodecanol, Phenoxyethanol, Polyquatemium-37, Rosemary (Rosmarinus Officinalis) Leaf Oil, Stearic Acid, Water (Aqua), Witch Hazel (Hamamelis Virginiana) Extract.

Questions or Comments?Call us toll free at 1(800)247-2405. Tuesday-Friday 8AM-6PM ET.

Equibal Labs®, PO Box 180, Unionville, NY 10988. Retain this insert for directions and information.

BlemFree.jpgBlemFree.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
199134salicylic acid 0.5 % Topical LotionPSN15
199134salicylic acid 5 MG/ML Topical LotionSCD15
199134salicylic acid 0.5 % Topical LotionSY15

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53228-002-01BlemFree118 mL in 1 TUBELOTION11815

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SALICYLIC ACIDACTIVE INGREDIENTO414PZ4LPZ1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZ1
BEHENTRIMONIUM METHOSULFATEINACTIVE INGREDIENT5SHP745C611
BENZETHONIUM CHLORIDEINACTIVE INGREDIENTPH41D057441
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN1
CHLORHEXIDINE GLUCONATEINACTIVE INGREDIENTMOR84MUD8E1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O1
HAMAMELIS VIRGINIANA TOPINACTIVE INGREDIENTUDA30A2JJY1
LEVOMENOLINACTIVE INGREDIENT24WE03BX2T1
MATRICARIA RECUTITAINACTIVE INGREDIENTG0R4UBI2ZZ1
MENTHYL LACTATE, (-)-INACTIVE INGREDIENT2BF9E65L7I1
OCTYLDODECANOLINACTIVE INGREDIENT461N1O614Y1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
POLYQUATERNIUM-37 (25000 MPA.S)INACTIVE INGREDIENT31L31U82851
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP1
WATERINACTIVE INGREDIENT059QF0KO0R1
WITCH HAZELINACTIVE INGREDIENT101I4J0U341

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53228-00253228-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
BUTYLENE GLYCOL3XUS85K0RAIACT
CETYL ALCOHOL936JST6JCNIACT
BEHENTRIMONIUM METHOSULFATE5SHP745C61IACT
BENZETHONIUM CHLORIDEPH41D05744IACT
LEVOMENOL24WE03BX2TIACT
CHLORHEXIDINE GLUCONATEMOR84MUD8EIACT
DIMETHICONE92RU3N3Y1OIACT
MATRICARIA RECUTITAG0R4UBI2ZZIACT
MENTHYL LACTATE, (-)-2BF9E65L7IIACT
OCTYLDODECANOL461N1O614YIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYQUATERNIUM-37 (25000 MPA.S)31L31U8285IACT
STEARIC ACID4ELV7Z65APIACT
WATER059QF0KO0RIACT
WITCH HAZEL101I4J0U34IACT
HAMAMELIS VIRGINIANA TOPUDA30A2JJYIACT
SALICYLIC ACIDO414PZ4LPZACTIB

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 1 · 12 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNLOTION / TOPICAL1140 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
BUTYLENE GLYCOLBUTYLENE GLYCOL3XUS85K0RASYSTEM / TOPICAL1400 mgExact identifier — unii+route
2 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APLOTION / TOPICAL80 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
BUTYLENE GLYCOLBUTYLENE GLYCOL3XUS85K0RASYSTEM / TOPICAL1400 mgExact identifier — unii+route
2 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNLOTION / TOPICAL1140 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
OCTYLDODECANOLOCTYLDODECANOL461N1O614YLOTION / TOPICAL714 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APLOTION / TOPICAL80 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
OCTYLDODECANOLOCTYLDODECANOL461N1O614YLOTION / TOPICAL714 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
BENZETHONIUM CHLORIDEBENZETHONIUM CHLORIDEPH41D05744CREAM / TOPICALNAExact identifier — unii+route
2 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
BENZETHONIUM CHLORIDEBENZETHONIUM CHLORIDEPH41D05744CREAM / TOPICALNAExact identifier — unii+route
2 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BlemFreeSALICYLIC ACIDEquibal, Inc.d6720efc-dbbe-4304-bb31-972b506a08bf2025-12-17WarningsExact identifier
ndc (package): 53228-002-01
ndc (product): 53228-002
ndc11 (package): 53228000201
spl id: 4630cfda-2b30-1d82-e063-6294a90aeb1e
spl set id: d6720efc-dbbe-4304-bb31-972b506a08bf

Reported adverse events (FAERS/openFDA)#

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