AcneFree Sensitive

Manufacturer
Valeant Pharmaceuticals North America LLC | Ei LLC
Effective date
2014-09-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:35:15

Label at a glance#

ProductAcneFree Sensitive 24 HOUR Acne Clearing System
Active ingredientBENZOYL PEROXIDE, SALICYLIC ACID
Label structure27 sections

Dosage and administration

  Apply to affected areas, avoiding eye area. Do not rinse. May also be used on face, chest, and back or throughout the day as a spot treatment. Recommended: Use as a spot treatment to start. Before using all-over face, gradually build skin’s tolerance by applying once every other night, then increasing application up to twice a day, morning and night.

Label contents#

Full prescribing information#

Hydrating Acne Repair Lotion + Spot Treatment

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzoyl Peroxide 3% w/v

Purpose

OTC - PURPOSE SECTION

Acne treatment

Use

INDICATIONS & USAGE SECTION

For the treatment of acne.

Warnings

WARNINGS SECTION

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 after 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 contact with hair and dyed fabrics, including carpets and clothing which may be bleached by this product.

Stop use and ask a doctor

OTC - STOP USE SECTION

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 immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply to affected areas, avoiding eye area. Do not rinse. May also be used on face, chest, and back or throughout the day as a spot treatment. Recommended: Use as a spot treatment to start. Before using all-over face, gradually build skin’s tolerance by applying once every other night, then increasing application up to twice a day, morning and night.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Ethyl Macadamiate, Propanediol, Glycerin, Butylene Glycol, Polyacrylamide, Phenoxyethanol, C13-14 Isoparaffin, Bisabolol, Laureth-7, Allantoin, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Methylisothiazolinone, Sodium Hyaluronate, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer, Sodium Hydroxide, Sea Whip Extract, Zingiber Officinale (Ginger) Root Extract

Other information

OTHER SAFETY INFORMATION

Store at 60°-95° F (15°-35° C).

Questions/Comments:

OTC - QUESTIONS SECTION

1-800-321-4576

Corrective Acne Cleanser

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 1.5% w/v

Purpose

OTC - PURPOSE SECTION

Acne treatment

Use

INDICATIONS & USAGE SECTION

For the treatment of acne.

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

For external use only.

Do not use

OTC - WHEN USING SECTION

  • If you have a known allergy to Salicylic Acid or aspirin.

When using this product

OTC - WHEN USING SECTION

  • with other topical acne medications at the same time or immediately following use of the product, dryness or irritation of the skin may be increased. If this occurs, only one medication should be used unless directed by a doctor.
  • Avoid contact with eyes. If contact occurs, flush thoroughly with water. Keep away from lips and mouth.
  • If you have aspirin sensitivity, consult a physician prior to use.

Stop use and ask a doctor

OTC - STOP USE SECTION

  • 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 immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

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 Ingredients

INACTIVE INGREDIENT SECTION

Water, Sodium Cocoyl Isethionate, Stearic Acid, Cocamidopropyl Betaine, Sodium Lauroamphoacetate, Disodium Laureth Sulfosuccinate, Glycol Distearate, Polyacrylate-1 Crosspolymer, Benzyl Alcohol, Avena Sativa (Oat) Kernel Extract, Sodium Phytate, Zinc PCA, Glycerin, Sorbic Acid, Ethyl Vanillin, Butylene Glycol, Sea Whip Extract, Aminomethyl Propanol

Other information

OTHER SAFETY INFORMATION

Store at 60°-95° F (15°-35° C).

Questions/Comments:

OTC - QUESTIONS SECTION

1-800-321-4576

Alcohol-Free Acne Toner

SPL UNCLASSIFIED SECTION

Warning:

WARNINGS SECTION

For external use only.

Directions

INDICATIONS & USAGE SECTION

Use every morning and evening. After cleansing, apply to entire face with a cotton pad, avoiding the eye area. Do not rinse. May also be used on chest or back.

Ingredients

INACTIVE INGREDIENT SECTION

Water, Niacinamide, Camellia Sinensis Leaf Extract, Pyrus Malus (Apple) Fruit Extract, Citrus Aurantium Dulcis (Orange) Fruit Extract, Citrus Medica Limonum (Lemon) Extract, Sea Whip Extract, Saccharum Officinarum (Sugar Cane) Extract, Zingiber Officinale (Ginger) Root Extract, Pentylene Glycol, Benzyl Alcohol, Isoceteth-20, Aminomethyl Propanol, Salicylic Acid, Disodium EDTA, Bisabolol, Benzalkonium Chloride, Glycerin, Sorbic Acid, Butylene Glycol

Questions/Comments:

OTC - QUESTIONS SECTION

1-800-321-4576

SPL UNCLASSIFIED SECTION

Distributed by: Valeant Consumer Products,

a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807

acnefree.com Made in USA ©2014 Rev. 03/14 9385400

PRINCIPAL DISPLAY PANEL - Kit Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AcneFree®

SENSITIVE

Sensitive Skin

24 HOUR Acne Clearing System

MORE

GENTLE than

PROACTIV* ®

the ONLY Sensitive Skin

24 HOUR Acne Clearing System

DERMATOLOGIST RECOMMENDED ACNE MEDICATION

Gentle on Skin – Hydrates & Minimizes Overdrying

Tough on Acne – Starts Clearing in 1-3 Days

CONTAINS: CLEANSER 4 FL OZ (118 mL), TONER 4 FL OZ (118 mL), LOTION 2 FL OZ (59 mL)

AcneFree Sensitive Part 1
AcneFree Sensitive Part 1

Principal Display Panel- 24 HOUR Acne Clearing System

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AcneFree Sensitive Part 2
AcneFree Sensitive Part 2

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AcneFree®

SENSITIVE


Hydrating

Acne Repair Lotion

+ Spot Treatment

Gentle Formula

___________________

Continuous-Relief

Micro-Benzoyl Peroxide

AcneFree Hydrating Acne Repair Lotion and Spot Treatment
AcneFree Hydrating Acne Repair Lotion and Spot Treatment

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AcneFree®

SENSITIVE

Corrective

Acne Cleanser

Gentle Formula

___________________

with Oat and Sea Whip

AcneFree Corrective Acne Cleanser
AcneFree Corrective Acne Cleanser

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BENZOYL PEROXIDEACTIVE INGREDIENTW9WZN9A0GM1
SALICYLIC ACIDACTIVE INGREDIENTO414PZ4LPZ1
BENZOYL PEROXIDEACTIVE MOIETYW9WZN9A0GM1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZ1
ALLANTOININACTIVE INGREDIENT344S277G0Z1
AMINOMETHYLPROPANOLINACTIVE INGREDIENTLU49E6626Q1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBH1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA1
C13-14 ISOPARAFFININACTIVE INGREDIENTE4F12ROE701
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KX1
DISODIUM LAURETH SULFOSUCCINATEINACTIVE INGREDIENTD6DH1DTN7E1
ETHYL MACADAMIATEINACTIVE INGREDIENTANA2NCS6V11
ETHYL VANILLININACTIVE INGREDIENTYC9ST449YJ1
GINGERINACTIVE INGREDIENTC5529G5JPQ1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
GLYCOL DISTEARATEINACTIVE INGREDIENT13W7MDN21W1
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4TH1
LAURETH-7INACTIVE INGREDIENTZ95S6G82011
LEVOMENOLINACTIVE INGREDIENT24WE03BX2T1
MELALEUCA ALTERNIFOLIA FLOWERING TOPINACTIVE INGREDIENT5AZ4S6N66F1
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMERINACTIVE INGREDIENTEG97988M5Q1
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFA1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
PHYTATE SODIUMINACTIVE INGREDIENT88496G1ERL1
PROPANEDIOLINACTIVE INGREDIENT5965N8W85T1
PSEUDOPTEROGORGIA ELISABETHAEINACTIVE INGREDIENTUDY3H1OUX51
SODIUM COCOYL ISETHIONATEINACTIVE INGREDIENT518XTE84931
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I1
SODIUM LAUROAMPHOACETATEINACTIVE INGREDIENTSLK428451L1
SORBIC ACIDINACTIVE INGREDIENTX045WJ989B1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP1
WATERINACTIVE INGREDIENT059QF0KO0R1
ZINC PIDOLATEINACTIVE INGREDIENTC32PQ86DH41

Products#

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

DailyMed product names page 1 of 1 · 34 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0187-16120187-1612-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 35 matching rows.

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 7 · 370 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSHAMPOO / TOPICAL1.25 %w/wExact identifier — unii candidate
50 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SUSPENSION / INTRAMUSCULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRADERMAL1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHGEL / TOPICAL185 mgExact identifier — unii candidate
50 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / BUCCAL34 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / INTRAVASCULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IGRANULE, FOR SUSPENSION / ORALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, EXTENDED RELEASE / ORAL265 mgExact identifier — unii candidate
75 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHCAPSULE, EXTENDED RELEASE / ORAL1.23 mgExact identifier — unii candidate
50 equally ranked IID candidates
ETHYL VANILLINETHYL VANILLINYC9ST449YJSUSPENSION / ORAL0.08 mg/5mlExact identifier — unii candidate
5 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / INTRADISCALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, EMULSION / INTRAVENOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, SUSPENSION / INTRASYNOVIAL18 mgExact identifier — unii candidate
50 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APPELLET / SUBCUTANEOUS0.97 mgExact identifier — unii candidate
26 equally ranked IID candidates
HYALURONATE SODIUMHYALURONATE SODIUMYSE9PPT4THINJECTION, SUSPENSION / INTRAMUSCULAR23 mgExact identifier — unii candidate
5 equally ranked IID candidates
HYALURONATE SODIUMHYALURONATE SODIUMYSE9PPT4THINJECTION, SUSPENSION / INTRAVITREAL23 mgExact identifier — unii candidate
5 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRATHECALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / INTRA-ARTICULAR1 %w/vExact identifier — unii candidate
50 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXMOUTHWASH / BUCCAL100 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, COATED / ORAL1 mgExact identifier — unii candidate
75 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BSOLUTION / OPHTHALMIC0.2 %w/vExact identifier — unii candidate
19 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR5.4 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISHAMPOO / TOPICAL3 mgExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION, EXTENDED RELEASE / ORAL2000 mgExact identifier — unii candidate
75 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BTABLET, COATED / ORAL1 mgExact identifier — unii candidate
19 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHCREAM / TOPICAL160 mgExact identifier — unii candidate
50 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IEMULSION / TOPICAL0.2 %w/wExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / INTRATHECALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, SOLUTION / INTRAVENOUS400 mgExact identifier — unii candidate
50 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRADERMALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii candidate
6 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IGEL / TOPICAL70 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / OPHTHALMIC0.05 %w/vExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii candidate
75 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / INTRACAVITARY0.01 mlExact identifier — unii candidate
50 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IMOUTHWASH / BUCCAL2 mg/1mlExact identifier — unii candidate
174 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHTABLET / ORAL1.06 mgExact identifier — unii candidate
50 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM, AUGMENTED / TOPICAL55 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL, FOAM / TOPICAL21 mgExact identifier — unii candidate
75 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BCONCENTRATE / ORAL1 mgExact identifier — unii candidate
19 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL / TOPICAL3 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TRANSDERMAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IGEL / OPHTHALMIC6 mgExact identifier — unii candidate
174 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXELIXIR / ORAL5621 mgExact identifier — unii candidate
75 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS144 mgExact identifier — unii candidate
50 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ITABLET, EXTENDED RELEASE / ORAL13 mgExact identifier — unii candidate
174 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APSOLUTION / TOPICALNAExact identifier — unii candidate
26 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUPPOSITORY / VAGINAL227.9 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRA-AMNIOTICADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRAVITREALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY / NASAL22.3 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXJELLY / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL, FOAM / TOPICAL72 mgExact identifier — unii candidate
6 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRACARDIACADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHLIQUID / INTRAVENOUS1.04 %w/vExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSUPPOSITORY / VAGINALNAExact identifier — unii candidate
50 equally ranked IID candidates
ETHYL VANILLINETHYL VANILLINYC9ST449YJPASTE / ORAL7 mgExact identifier — unii candidate
5 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IFILM / BUCCAL0.09 mgExact identifier — unii candidate
174 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
fabce85e-43e6-4b04-8341-b702fd35214ed5693b98-6fb6-42f0-b01e-b5c2651d14202014-09-11WarningsExact identifier
spl set id: d5693b98-6fb6-42f0-b01e-b5c2651d1420

Reported adverse events (FAERS/openFDA)#

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