FDA.reportPublic FDA data

AF Foam Clear Skin Acne Pore Cleanser

Manufacturer
University Medical Pharmaceuticals Corp | Universal Packaging Systems, INC
Effective date
2011-12-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:30:17

Label at a glance#

ProductAF Foam Clear Skin Acne Pore Cleanser
Active ingredientBenzoyl Peroxide
Label structure13 sections

Storage and handling

Other Information Store at 60 o -85 o F (15 o -30 o C). Pressurized container: protect from sunlight and do not expose to temperatures exceeding 120 o F(49 o C). Do not puncture or birn, even after use. Use only as directed.

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 AM and PM. Recommended: After AM use, follow with AcneFree All-Day Acne Control. After PM use, follow with 3-in-1 Acne Night Repair.
  • Moisten skin.
  • Shake well before each use.
  • Hold Can upright and press down firmly on dispenser. Apply a small amount of foam (not more than a dollop the size of a gold ball) into hand.
  • Using fingers, apply to face and gently massage to cleanse.
  • Rinse thoroughly with warn water and pat dry.
  • If bothersome peeling occurs, reduce application use.
  • If going outside, use a sunscreen.

INACTIVE INGREDIENT SECTION

Inactive ingredients: Benzylkonium Chloride, Caprylic/Capric Triglyceride, Cetyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Decyl Glucoside, Disodium Laureth Sulfosuccinate, Ethylhexylglycerin, Glycerin,  Glyceryl Sterate, Isobutane, Magnesium Aluminum Silicate, Methylisothiazolinone, PEG-100 Stearate, Phenoxyethanol, Polyethylene, Propane, Sea Whip Extract, Sodium Benzoate, Sodium Polyacrylate, Stearic Acid, Water, Xanthan Gum.

STORAGE AND HANDLING SECTION

Other Information
  • Store at 60o-85oF (15o-30oC).
  • Pressurized container: protect from sunlight and do not expose to temperatures exceeding 120oF(49oC). Do not puncture or birn, even after use. Use only as directed.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AcneFree Clear Skin treatments

Oil-Free Acne Pore Cleanser
Micro-Benzoyl Peroxide 2.5%

Rinse-Off Foam
Medicine Stays in Pores Even After Rinsing
Drug Facts 1
Drug Facts 1
Drug Facts 2
Drug Facts 2
Label
Label



DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
845836benzoyl peroxide 2.5 % Medicated Liquid SoapPSN1
845836benzoyl peroxide 25 MG/ML Medicated Liquid SoapSCD1
845836benzoyl peroxide 2.5 % Medicated Liquid SoapSY1

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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50544-301-402019-11-13C16284748780-197449f38-b7b0-f6ea-e053-dbdaa90aa703AF Foam CS Acne Pore Cleanser

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50544-301-40AF Foam Clear Skin Acne Pore Cleanser85 g in 1 CANAEROSOL, FOAM851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50544-301AF FOAM CLEAR SKIN ACNE PORE CLEANSER (BENZOYL PEROXIDE) AEROSOL, FOAM [UNIVERSITY MEDICAL PHARMACEUTICALS CORP]1Legacy NDC, 1 package rows20111209_315e4325-bda4-44ae-b7c8-c2744bfcd3fa.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Benzoyl PeroxideACTIVE INGREDIENTW9WZN9A0GM1
Benzoyl PeroxideACTIVE MOIETYW9WZN9A0GM1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W71
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN1
DECYL GLUCOSIDEINACTIVE INGREDIENTZ17H97EA6Y1
DISODIUM LAURETH SULFOSUCCINATEINACTIVE INGREDIENTD6DH1DTN7E1
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3P1
glycerinINACTIVE INGREDIENTPDC6A3C0OX1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE41
HIGH DENSITY POLYETHYLENEINACTIVE INGREDIENTUG00KM4WR71
isobutaneINACTIVE INGREDIENTBXR49TP6111
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NC1
MATRICARIA RECUTITAINACTIVE INGREDIENTG0R4UBI2ZZ1
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7U1
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFA1
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999R1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
propaneINACTIVE INGREDIENTT75W9911L61
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 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50544-30150544-301-40

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
DECYL GLUCOSIDEZ17H97EA6YIACT
MATRICARIA RECUTITAG0R4UBI2ZZIACT
propaneT75W9911L6IACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
PSEUDOPTEROGORGIA ELISABETHAEUDY3H1OUX5IACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
XANTHAN GUMTTV12P4NEEIACT
CETYL ALCOHOL936JST6JCNIACT
isobutaneBXR49TP611IACT
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 · 300 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSUSPENSION / ORAL320 mgExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUPOWDER, FOR SUSPENSION / ORAL160 mgExact identifier — unii candidate
35 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION/ DROPS / AURICULAR (OTIC)25 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSUPPOSITORY / RECTAL440 mgExact identifier — unii candidate
75 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEPOWDER / ORAL275 mgExact identifier — unii candidate
29 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUPASTE / ORAL28 mgExact identifier — unii candidate
35 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNTABLET, EXTENDED RELEASE / ORAL132 mgExact identifier — unii candidate
20 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEGEL / TOPICAL58 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
XANTHAN GUMXANTHAN GUMTTV12P4NEETROCHE / ORAL948 mgExact identifier — unii candidate
29 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNOINTMENT / TOPICAL7 %w/wExact identifier — unii candidate
20 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCLIQUID / ORAL82 mg/5mlExact identifier — unii candidate
17 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNAEROSOL, FOAM / RECTAL17 mgExact identifier — unii candidate
20 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNAEROSOL, FOAM / TOPICAL82 mgExact identifier — unii candidate
20 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / OPHTHALMIC2.5 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APAEROSOL, FOAM / VAGINAL4 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / BUCCAL34 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4AEROSOL, FOAM / VAGINAL3 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UINJECTION, EMULSION / INTRAVENOUS1.1 %w/vExact identifier — unii candidate
18 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNSUSPENSION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
20 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEECREAM / TOPICAL46 mgExact identifier — unii candidate
29 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii candidate
75 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APOINTMENT / TOPICAL15 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7CAPSULE / ORAL10 mgExact identifier — unii candidate
18 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION, SUSPENSION / SUBCUTANEOUS1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4EMULSION / ORALNAExact identifier — unii candidate
21 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7INJECTION / INTRAMUSCULAR1 mgExact identifier — unii candidate
24 equally ranked IID candidates
isobutaneISOBUTANEBXR49TP611AEROSOL, SPRAY / TOPICAL4484 mgExact identifier — unii candidate
4 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCSUSPENSION / ORAL5000 mg/5mlExact identifier — unii candidate
17 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION, EMULSION / INTRAVENOUS24100 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / DENTAL15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UOINTMENT / TOPICAL20 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, EXTENDED RELEASE / ORAL528 mgExact identifier — unii candidate
29 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SHAMPOO / TOPICAL0.2 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCAPSULE / ORAL8.5 mgExact identifier — unii candidate
35 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii candidate
6 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4TABLET, DELAYED RELEASE / ORAL6 mgExact identifier — unii candidate
21 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / BUCCAL6 mgExact identifier — unii candidate
26 equally ranked IID candidates
isobutaneISOBUTANEBXR49TP611AEROSOL, FOAM / RECTAL142 mgExact identifier — unii candidate
4 equally ranked IID candidates
propanePROPANET75W9911L6AEROSOL, FOAM / TOPICAL55 %w/wExact identifier — unii candidate
2 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7GEL / TOPICAL26 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNSUSPENSION / AURICULAR (OTIC)1 %w/vExact identifier — unii candidate
20 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, FILM COATED / ORAL176 mgExact identifier — unii candidate
26 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET, COATED / ORAL0.2 mgExact identifier — unii candidate
35 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXEMULSION / INTRAVENOUS2.2 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APCAPSULE, EXTENDED RELEASE / ORAL64 mgExact identifier — unii candidate
26 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUELIXIR / ORAL5.02 mg/5mlExact identifier — unii candidate
35 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC0.6 %w/wExact identifier — unii candidate
29 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UTABLET / ORAL2 mgExact identifier — unii candidate
18 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCCONCENTRATE / ORAL410 mg/5mlExact identifier — unii candidate
17 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION / SUBCUTANEOUS450 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXEMULSION / OPHTHALMIC3 mgExact identifier — unii candidate
75 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SUSPENSION/ DROPS / OPHTHALMIC0.02 %w/vExact identifier — unii candidate
24 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXGEL / OPHTHALMIC0.88 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4SUSPENSION / AURICULAR (OTIC)0.5 %w/vExact identifier — unii candidate
21 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL / TOPICAL1.05 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGEL / DENTAL0.08 %w/wExact identifier — unii candidate
35 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, FILM COATED, EXTENDED RELEASE / ORAL120 mgExact identifier — unii candidate
26 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXLIQUID / TOPICAL2.5 %w/wExact 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
dbf02fdc-bab0-4fab-a9ba-d92cfd134704315e4325-bda4-44ae-b7c8-c2744bfcd3fa2011-12-08WarningsExact identifier
spl id: dbf02fdc-bab0-4fab-a9ba-d92cfd134704
spl set id: 315e4325-bda4-44ae-b7c8-c2744bfcd3fa

Reported adverse events (FAERS/openFDA)#

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