FDA.reportPublic FDA data

AcneFree Severe Terminator

Manufacturer
Valeant Pharmaceuticals North America LLC | Ei LLC
Effective date
2017-02-22
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 01:19:02

Label at a glance#

ProductAcneFree Severe Terminator Maximum Strength
Active ingredientBENZOYL PEROXIDE
Label structure12 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 ▪ if going outsi...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzoyl peroxide 10% w/v

Purpose

OTC - PURPOSE SECTION

Acne treatment

Use

INDICATIONS & USAGE SECTION

for the treatment of acne

Warnings

WARNINGS SECTION

For external use only

Do not use if you

OTC - DO NOT USE SECTION

  • have sensitive skin
  • are sensitive to benzoyl peroxide

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.
  • rinse right away with water if it gets in eyes
  • avoid unnecessary sun exposure and use a sunscreen
  • avoid contact with the eyes, lips and mouth
  • avoid contact with hair and dyed fabrics, which may be bleached by this product
  • skin irritation may occur, characterized by redness, burning, itching, peeling or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.

Stop use and ask a doctor if

OTC - STOP USE SECTION

skin irritation becomes severe

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center 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
  • if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

acrylates/C10-30 alkyl acrylate crosspolymer, benzalkonium chloride, bisabolol, butylene glycol, chamomilla recutita (matricaria) flower extract, ethylhexylglycerin, glycerin, methyl methacrylate/glycol dimethacrylate crosspolymer, methylpropanediol, phenoxyethanol, sea whip extract, sodium benzoate, sodium hydroxide, tetrasodium EDTA, water, zingiber officinale (ginger) root extract.

Questions/comments?

OTC - QUESTIONS SECTION

1-800-321-4576

acnefree.com

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAXIMUM

STRENGTH

AcneFree®

SEVERE

PRESCRIPTION GRADE

Acne Spot Treatment

Attacks the source of your breakouts

Also contains

Chamomile, Ginger, and Sea Whip

MAXIMUM STRENGTH

TERMINATOR 10®

Advanced 10% Micro-Benzoyl Peroxide

NET WT. 1 OZ. (28 g)

AcneFree Acne Spot Treatment Terminator 10 - 1 oz Carton
AcneFree Acne Spot Treatment Terminator 10 - 1 oz Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0187-1616-012021-05-11C16284748780-19d75b9d0-557b-f424-e053-dadaa90a57ceDrug Facts
0187-1616-012020-01-31C16284748780-19d75b9d0-557b-f424-e053-dadaa90a57ceDrug Facts

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BENZOYL PEROXIDEACTIVE INGREDIENTW9WZN9A0GM2
BENZOYL PEROXIDEACTIVE MOIETYW9WZN9A0GM2
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W72
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA2
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)INACTIVE INGREDIENT59TL3WG5CO2
CHAMOMILEINACTIVE INGREDIENTFGL3685T2X2
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LU2
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3P2
GINGERINACTIVE INGREDIENTC5529G5JPQ2
GLYCERININACTIVE INGREDIENTPDC6A3C0OX2
LEVOMENOLINACTIVE INGREDIENT24WE03BX2T2
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMERINACTIVE INGREDIENTEG97988M5Q2
METHYLPROPANEDIOLINACTIVE INGREDIENTN8F53B3R4R2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T2
PSEUDOPTEROGORGIA ELISABETHAEINACTIVE INGREDIENTUDY3H1OUX52
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I2
WATERINACTIVE INGREDIENT059QF0KO0R2

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
0187-16160187-1616-01

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
BENZOYL PEROXIDEW9WZN9A0GMACTIB
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
LEVOMENOL24WE03BX2TIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
CHAMOMILEFGL3685T2XIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERINPDC6A3C0OXIACT
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMEREG97988M5QIACT
METHYLPROPANEDIOLN8F53B3R4RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PSEUDOPTEROGORGIA ELISABETHAEUDY3H1OUX5IACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM HYDROXIDE55X04QC32IIACT
EDETATE SODIUMMP1J8420LUIACT
WATER059QF0KO0RIACT
GINGERC5529G5JPQIACT

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 6 · 330 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IGEL, METERED / TRANSDERMAL350 mgExact identifier — unii candidate
174 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7LIQUID / NASAL0.2 mg/1mlExact identifier — unii candidate
24 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGRANULE, FOR SUSPENSION / ORAL120 mgExact identifier — unii candidate
35 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUINJECTION, SOLUTION / INTRAVENOUS0.04 %w/vExact identifier — unii candidate
12 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUINJECTION, SOLUTION / INTRAMUSCULAR4.8 %w/vExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ICREAM, AUGMENTED / TOPICAL6 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISYRUP / ORAL71 mg/5mlExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ITABLET, EXTENDED RELEASE / ORAL13 mgExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SUSPENSION / SUBCUTANEOUS1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SUSPENSION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRATUMORADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / OPHTHALMIC6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYSTEM / IONTOPHORESIS168.1 mgExact identifier — unii candidate
75 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION / AURICULAR (OTIC)0.01 %w/vExact identifier — unii candidate
24 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUSOAP / TOPICAL0.12 %w/wExact identifier — unii candidate
12 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISUSPENSION / OPHTHALMICADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
BUTYLENE GLYCOLBUTYLENE GLYCOL3XUS85K0RASYSTEM / TOPICAL1400 mgExact identifier — unii candidate
2 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ILOTION / TOPICAL21 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IMOUTHWASH / BUCCAL2 mg/1mlExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDROPS / ORAL300 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRATHECALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / SUBCUTANEOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ICAPSULE, COATED / ORAL0.08 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SUSPENSION / INTRAVENOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRA-ARTERIALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ILIQUID / ORAL2 mg/5mlExact identifier — unii candidate
174 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / URETERALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGRANULE / ORALNAExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUFILM / BUCCAL1 mgExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRA-ARTICULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, CHEWABLE / ORAL12 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, FILM COATED / ORAL1.55 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / TOPICAL2.5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IJELLY / TOPICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ICAPSULE, COATED PELLETS / ORAL0.01 mgExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXELIXIR / ORAL5621 mgExact identifier — unii candidate
75 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SUSPENSION / AURICULAR (OTIC)0.01 %w/vExact identifier — unii candidate
24 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / OPHTHALMIC2.5 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, EXTENDED RELEASE / ORAL265 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY / NASAL22.3 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION/ DROPS / TOPICAL0.01 %w/vExact identifier — unii candidate
24 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY, METERED / NASAL13 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ITABLET / ORAL10 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IFILM, EXTENDED RELEASE / TRANSDERMAL0.85 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / SUBMUCOSALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS136.55 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUPASTE / ORAL28 mgExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISUSPENSION/ DROPS / TOPICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE / DENTAL20 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGEL / TOPICAL5 mgExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSYRUP / ORAL80 mgExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRACAVITARYADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / OPHTHALMIC12 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii candidate
75 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION / OPHTHALMIC2 %w/vExact identifier — unii candidate
24 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAVENOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRABURSALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSHAMPOO / TOPICAL5 %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
743fd8b8-794f-4d19-a620-bd640b14e25606635f3f-93b6-4602-9bed-f426b28f69162017-02-22WarningsExact identifier
spl set id: 06635f3f-93b6-4602-9bed-f426b28f6916

Reported adverse events (FAERS/openFDA)#

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