FDA.reportPublic FDA data

Oil-Free Acne Cleanser

Manufacturer
University Medical Pharmaceuticals Corp | Universal Packaging Systems, INC
Effective date
2011-11-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:29:59

Label at a glance#

ProductOil-Free Acne Cleanser
Active ingredientBenzoyl Peroxide
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Benzoyl Peroxide 2.5% w/v

OTC - PURPOSE SECTION

Purpose: Acne Treatment

INDICATIONS & USAGE SECTION

Use for the treatment of acne.

WARNINGS SECTION

Warnings For external use only.

OTC - DO NOT USE SECTION

Do not use: If you are sensitive to Benzoyl Peroxide or have very sensitive skin. This product may cause irritation.

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use: If you are using other topical acne drugs at the same time or right before use of this product. This may increase dryness, redness or irritation of the skin. If this occurs, only one medication should be used unless a doctor directs otherwise.

OTC - WHEN USING SECTION

When using this product:
  • Avoid contact with eyes. If contact occurs, flush thoroughly with water. Keep away from lips and mouth.
  •  Avoid unnecessary sun exposure and use a sunscreen.
  • Avoid product with hair and dyed fabrics, including carpets and clothing which may be bleached by this product.

OTC - STOP USE SECTION

Stop use and ask a doctor: If excessive irritation occurs.

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.

DOSAGE & ADMINISTRATION SECTION

Directions: Use every morning and evening. Apply a dime-size amount to damp skin and gently massage, avoiding the eye area. Rinse well. If bothersome peeling occurs, reduce application use. May also be used on chest or back.

INACTIVE INGREDIENT SECTION

Inactive ingredients: Water, Disodium Laureth Sulfosuccinate, Glyceryl Stearate, PEG-100 Stearate, Stearic Acid, Glycerin, Cocamidopropyl Betaine, Bakuchiol, Panthenyl Triacetate, Bisabolol, Benzalkonium Chloride, Chamomilla Recuita (Matricaria) Flower Extract, Naringenin, Sea Whip Extract, Polyethylene, Xanthan Gum, Cetyl Alcohol, Magnesium Aluminum Silicate, Sodium Benzoate, Caprylic/Capric Triglyeride, Farnesol, Phenoxyethanol, Ethylhexylglycerin, Methylisothiazolinone.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AcneFree Clear Skin Treatments

Oil-Free Acne Cleanser
Gentle Exfoliating Microbeads

Advanced Micro-Benzoyl Peroxide
Artwork for Bottle
Artwork for Bottle

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308688benzoyl peroxide 2.5 % Topical CreamPSN1
308688benzoyl peroxide 25 MG/ML Topical CreamSCD1
308688benzoyl peroxide 2.5 % Topical CreamSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BENZOIC ACID Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a46239a7-5963-4008-8cbb-6b9000f497ebProduct name120250721
b382b4e1-6b48-45f6-bffc-e61b00b0ce19Product name320250317
d9d61457-6a5a-41fc-b418-e5479a2904b7Product name220230303
32012d5c-25ac-49c7-9d4c-1313177fff7cProduct name120230112
13e7e7e3-e885-4c79-af6d-dad1aedbb06eProduct name120220128
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
4a7d44fe-774d-404b-aad0-8a90fe78375aProduct name420211025
3f45980c-c196-47e5-0e5e-48b7c57327c5Product name520200428
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50544-001-062019-11-13C16284748780-197449f38-b8b2-f6ea-e053-dbdaa90aa703Oil-Free Acne Cleanser

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50544-001-06Oil-Free Acne Cleanser237 g in 1 BOTTLE, PLASTICCREAM2371

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50544-001OIL-FREE ACNE CLEANSER (BENZOYL PEROXIDE) CREAM [UNIVERSITY MEDICAL PHARMACEUTICALS CORP]1Legacy NDC, 1 package rows20111102_3e284042-8054-47c3-8051-e16782bf6d8c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Benzoyl PeroxideACTIVE INGREDIENTW9WZN9A0GM1
benzoic acidACTIVE MOIETY8SKN0B0MIM1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W71
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN1
CETYL ESTERS WAXINACTIVE INGREDIENTD072FFP9GU1
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KX1
DISODIUM LAURETH SULFOSUCCINATEINACTIVE INGREDIENTD6DH1DTN7E1
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3P1
glycerinINACTIVE INGREDIENTPDC6A3C0OX1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE41
HIGH DENSITY POLYETHYLENEINACTIVE INGREDIENTUG00KM4WR71
LEVOMENOLINACTIVE INGREDIENT24WE03BX2T1
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NC1
MATRICARIA RECUTITAINACTIVE INGREDIENTG0R4UBI2ZZ1
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7U1
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFA1
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999R1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
PSEUDOPTEROGORGIA ELISABETHAEINACTIVE INGREDIENTUDY3H1OUX51
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP1
waterINACTIVE INGREDIENT059QF0KO0R1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE1

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50544-00150544-001-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
Benzoyl PeroxideW9WZN9A0GMACTIB
water059QF0KO0RIACT
DISODIUM LAURETH SULFOSUCCINATED6DH1DTN7EIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-100 STEARATEYD01N1999RIACT
STEARIC ACID4ELV7Z65APIACT
glycerinPDC6A3C0OXIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
MATRICARIA RECUTITAG0R4UBI2ZZIACT
LEVOMENOL24WE03BX2TIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
PSEUDOPTEROGORGIA ELISABETHAEUDY3H1OUX5IACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
XANTHAN GUMTTV12P4NEEIACT
CETYL ALCOHOL936JST6JCNIACT
CETYL ESTERS WAXD072FFP9GUIACT
SODIUM BENZOATEOJ245FE5EUIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT

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 · 299 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
STEARIC ACIDSTEARIC ACID4ELV7Z65APEMULSION / TOPICALNAExact identifier — unii candidate
26 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCLOTH / TOPICAL0.05 mg/mgExact identifier — unii candidate
75 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7INJECTION / INTRALESIONAL1 mgExact identifier — unii candidate
24 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUPOWDER, FOR SOLUTION / ORAL98 mgExact identifier — unii candidate
35 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION/ DROPS / ORAL22 mgExact identifier — unii candidate
29 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7INJECTION / INTRAMUSCULAR1 mgExact identifier — unii candidate
24 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7USOLUTION / ORAL5566 mgExact identifier — unii candidate
18 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC0.6 %w/wExact identifier — unii candidate
29 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7SUPPOSITORY / VAGINALNAExact identifier — unii candidate
18 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, ORALLY DISINTEGRATING / ORAL10 mgExact identifier — unii candidate
26 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4EMULSION / ORALNAExact identifier — unii candidate
21 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCCAPSULE / ORAL60 mgExact identifier — unii candidate
17 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXLIQUID / TOPICAL2.5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNSOLUTION / TOPICALNAExact identifier — unii candidate
20 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7LIQUID / NASAL0.2 mg/1mlExact identifier — unii candidate
24 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCSYRUP / ORAL100 mg/1mlExact identifier — unii candidate
17 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UCAPSULE / ORAL4771 mgExact identifier — unii candidate
18 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGEL / RECTAL406 mgExact identifier — unii candidate
35 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEELOZENGE / ORAL1264 mgExact identifier — unii candidate
29 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCSUSPENSION / RECTAL14480 mgExact identifier — unii candidate
17 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNSUSPENSION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
20 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL36 mgExact identifier — unii candidate
29 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSHAMPOO / TOPICAL5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCOINTMENT / VAGINAL231 mgExact identifier — unii candidate
17 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXPASTE / ORAL3822 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSUSPENSION / ORAL320 mgExact identifier — unii candidate
35 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, ORALLY DISINTEGRATING / ORAL0.15 mgExact identifier — unii candidate
29 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SHAMPOO / TOPICAL0.2 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
CETYL ESTERS WAXCETYL ESTERS WAXD072FFP9GULOTION / TOPICAL1 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UINJECTION, EMULSION / INTRAVENOUS1.1 %w/vExact identifier — unii candidate
18 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / OPHTHALMIC6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APSHAMPOO / TOPICAL9.7 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4AEROSOL, FOAM / VAGINAL3 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7CLOTH / TOPICALNAExact identifier — unii candidate
24 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEFILM, SOLUBLE / ORAL1 mgExact identifier — unii candidate
29 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL23 mgExact identifier — unii candidate
21 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEPASTE / ORAL1050 mgExact identifier — unii candidate
29 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCTABLET, CHEWABLE / ORAL12 mgExact identifier — unii candidate
17 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APOINTMENT / TOPICAL15 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGRANULE, EFFERVESCENT / ORAL60 mgExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCONCENTRATE / ORAL20 mgExact identifier — unii candidate
35 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UAEROSOL, FOAM / TOPICAL10.87 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSPRAY, METERED / NASAL13 mgExact identifier — unii candidate
75 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNTABLET, COATED / ORAL0.25 mgExact identifier — unii candidate
20 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNLOTION / TOPICAL1140 mgExact identifier — unii candidate
20 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCPASTE, DENTIFRICE / DENTAL0.4 %w/wExact identifier — unii candidate
17 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SPRAY, METERED / NASAL1 mgExact identifier — unii candidate
24 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / BUCCAL34 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS225 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSUSPENSION, EXTENDED RELEASE / ORAL24 mgExact identifier — unii candidate
35 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION / RECTAL452 mgExact identifier — unii candidate
29 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UPOWDER / SUBLINGUAL2 mgExact identifier — unii candidate
18 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APSOAP / TOPICAL6 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESOLUTION / OPHTHALMIC0.6 %w/vExact identifier — unii candidate
29 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSUSPENSION / ORAL26208 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4GRANULE, FOR SUSPENSION / ORAL4 mgExact identifier — unii candidate
21 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION/ DROPS / OPHTHALMIC1 mgExact identifier — unii candidate
24 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXTABLET, CHEWABLE / ORAL12 mgExact 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
038390ce-8684-4c27-98dc-9521d0e3964b3e284042-8054-47c3-8051-e16782bf6d8c2011-11-01WarningsExact identifier
spl id: 038390ce-8684-4c27-98dc-9521d0e3964b
spl set id: 3e284042-8054-47c3-8051-e16782bf6d8c

Reported adverse events (FAERS/openFDA)#

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