Benzac

Manufacturer
Galderma Laboratories, L.P. | Accupac, Inc.
Effective date
2015-01-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:34:05

Label at a glance#

ProductBenzac
Active ingredientSALICYLIC ACID
Label structure8 sections

Label contents#

Full prescribing information#

Active Ingredient........Purpose

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 0.5%............Acne treatment

Use

INDICATIONS & USAGE SECTION

• For the treatment of acne

• Penetrates pores to eliminate most acne blemishes and help prevent new ones from forming

Warnings

WARNINGS SECTION

For external use only

When using this product

• 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.

Stop use and ask a doctor if

Irritation becomes severe.

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.

Do not use around eye area. If contact occurs, flush thoroughly with water. If irratation develops, discontinue use.»

DOSAGE & ADMINISTRATION SECTION

Drug Facts (continued)

Directions

• wet face. Pump a small amount of cleanser onto wet palms. Gently massage the cleanser all over your face for about 20-30 seconsd, avoiding the eye area. Rinse thoroughly, then pat dry.

• because excesssive drying of the skin may occur, start with one application daily, then gradually increase to two times daily as needed or as directed by a doctor

• if bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Alcohol Denatured, Backhousia Citriodora Leaf Extract, Butylene Glycol, Caprylic/Capric Triglyceride, Citric Acid, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Grandis (Grapefruit) Peel Oil, Citrus Reticulate (Tangerine) Peel Oil, Glycerin, Glycine Soja (Soybean) Oil, Lauramidopropyl Betaine, Lonicera Caprifolium (Honeysuckle) Flower Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Phenoxyethanol, Polysorbate 80, Potassium Benzoate, Potassium Sorbate, Santalum Album (Sandalwood) Oil, Sodium Laurylglucosides Hydroxypropylsulfonate, Terminalia Ferdinandiana Fruit Extract, Tocopherol, Water

Questions or comments?

OTC - QUESTIONS SECTION

1-866-735-4137

Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

P52488-0-benzac-afc-lbl-frntP52488-0-benzac-afc-lbl-frnt

P52488-0-benzac-afc-lbl-backP52488-0-benzac-afc-lbl-back

GALDERMA

BENZAC®

ACNE SOLUTIONS

Peel for Drug Facts

Skin Balancing Foaming Cleanser

With calming and soothing East Indian Sandalwood Oil

1 CLEANSE

0.5% Salicylic Acid

6 FL OZ (177 mL)

Skin Balancing Foaming Cleanser

is proven to gently exfoliate the skin, remove excess oil, and soothe breakouts without overdrying the skin. Instant foam minimizes irritation.

  • Dermatologist developed
  • Non-Comedogenic
  • Free of sulfates, artificial fragrance, dyes & preservatives

302993674061

From the makers of the world's leading branded topical acne prescription medication, Benzac Acne Solutions regimen is clniically proven to fight acne at its source and break the acne cycle.

Distributed by:

Galderma Laboratories, L.P.

Fort Worth TX 76177 USA

GALDERMA is a registered trademark

Made in USA

P52488-0

East Indian Sandalwood is one of nature's rare and ancient healers. Now, sustainably grown in a rehabilitated forest, the oil is extracted using renewable energy, resulting in the world's only therapeutic grade of East Indian Sandalwood Oil.

This exceptional ingredient, which is reported to have gentle anti-bacterial and anti-inflammatory properties, is the secret to our clinically proven acne-fighting formulas, designed to help give you clear and healthy skin.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SALICYLIC ACIDACTIVE INGREDIENTO414PZ4LPZ2
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZ2
ALCOHOLINACTIVE INGREDIENT3K9958V90M2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSL2
BACKHOUSIA CITRIODORA LEAFINACTIVE INGREDIENTFKN73KG7472
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA2
CITRUS MAXIMA FRUIT RIND OILINACTIVE INGREDIENT8U3877WD442
GLYCERININACTIVE INGREDIENTPDC6A3C0OX2
KAKADU PLUMINACTIVE INGREDIENT0ZQ1D2FDLI2
LAURAMIDOPROPYL BETAINEINACTIVE INGREDIENT23D6XVI2332
LONICERA CAPRIFOLIUM FLOWERINACTIVE INGREDIENT5N1WD9784U2
LONICERA JAPONICA FLOWERINACTIVE INGREDIENT4465L2WS4Y2
MANDARIN OILINACTIVE INGREDIENTNJO720F72R2
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7U2
ORANGE OILINACTIVE INGREDIENTAKN3KSD11B2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8H2
POTASSIUM BENZOATEINACTIVE INGREDIENT763YQN2K7K2
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ42
SANDALWOOD OILINACTIVE INGREDIENTX7X01WMQ5F2
SOYBEAN OILINACTIVE INGREDIENT241ATL177A2
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P82
WATERINACTIVE INGREDIENT059QF0KO0R2

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
0299-36740299-3674-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 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 6 · 336 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAMUSCULAR15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLINJECTION, SOLUTION / INTRAVENOUS772 mgExact identifier — unii candidate
61 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / AURICULAR (OTIC)0.05 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
SOYBEAN OILSOYBEAN OIL241ATL177AAEROSOL, FOAM / TOPICAL50 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / NASAL25 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE / ORAL3487 mgExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, SUSPENSION / INTRAVITREAL0.02 %w/vExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HPASTE / ORAL28 mgExact identifier — unii candidate
78 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSOLUTION / TOPICAL4.35 %w/vExact identifier — unii candidate
61 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLELIXIR / ORAL90 mgExact identifier — unii candidate
61 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSUSPENSION / ORAL206 mgExact identifier — unii candidate
78 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SUSPENSION / SUBCUTANEOUS1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8CAPSULE, COATED / ORAL0.25 mgExact identifier — unii candidate
5 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UPOWDER / SUBLINGUAL2 mgExact identifier — unii candidate
18 equally ranked IID candidates
SOYBEAN OILSOYBEAN OIL241ATL177AINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS10 %w/vExact identifier — unii candidate
7 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLPASTE / ORAL26 mgExact identifier — unii candidate
61 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4PASTE / ORAL48 mgExact identifier — unii candidate
19 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSUSPENSION/ DROPS / ORAL15 mgExact identifier — unii candidate
61 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4CAPSULE / ORALNAExact identifier — unii candidate
19 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCLOTH / TOPICAL0.05 mg/mgExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HTABLET / ORAL233 mgExact identifier — unii candidate
78 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UAEROSOL, FOAM / TOPICAL10.87 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, CHEWABLE / ORAL12 mgExact identifier — unii candidate
75 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UOINTMENT / TOPICAL20 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4TABLET / ORAL6 mgExact identifier — unii candidate
19 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / SUBCUTANEOUS450 mgExact identifier — unii candidate
75 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET, EXTENDED RELEASE / ORAL312 mgExact identifier — unii candidate
61 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSPRAY / NASAL5 mgExact identifier — unii candidate
61 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDROPS / NASAL10 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION / INTRASYNOVIAL0.2 %w/vExact identifier — unii candidate
78 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLFILM, SOLUBLE / ORAL7 mgExact identifier — unii candidate
61 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSUSPENSION / RESPIRATORY (INHALATION)1 mgExact identifier — unii candidate
61 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSUSPENSION / SUBCUTANEOUS0.3 %w/vExact identifier — unii candidate
78 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4CREAM / TOPICAL0.25 %w/wExact identifier — unii candidate
19 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UPOWDER, FOR SUSPENSION / ORAL3390 mg/5mlExact identifier — unii candidate
18 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / AURICULAR (OTIC)25 mgExact identifier — unii candidate
75 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8CREAM / TOPICALNAExact identifier — unii candidate
5 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRAVENOUS33750 mgExact identifier — unii candidate
75 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSOLUTION, CONCENTRATE / INTRAVENOUS60 mgExact identifier — unii candidate
61 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLCREAM / TOPICAL1 mgExact identifier — unii candidate
61 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, SUSPENSION / INTRAVENOUS0.5 %w/vExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSUPPOSITORY / VAGINAL28 mgExact identifier — unii candidate
78 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLCAPSULE, LIQUID FILLED / ORAL360 mgExact identifier — unii candidate
61 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION / INTRAVENOUS4680 mgExact identifier — unii candidate
78 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLPOWDER, FOR SOLUTION / ORAL123 mgExact identifier — unii candidate
61 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSUSPENSION/ DROPS / OPHTHALMIC0.05 %w/vExact identifier — unii candidate
61 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, SUSPENSION / INTRALESIONAL4 mgExact identifier — unii candidate
78 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLINJECTION / PERINEURAL0.02 %w/vExact identifier — unii candidate
61 equally ranked IID candidates
BUTYLENE GLYCOLBUTYLENE GLYCOL3XUS85K0RASYSTEM / TOPICAL1400 mgExact identifier — unii candidate
2 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLCAPSULE / ORAL131 mgExact identifier — unii candidate
61 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / SUBCUTANEOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSOLUTION/ DROPS / AURICULAR (OTIC)1 mgExact identifier — unii candidate
61 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY, METERED / NASAL13 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
0dd67012-6278-4c04-ae23-f4872995d773e6e59e84-7bca-46b0-8335-258632d26f772015-01-08WarningsExact identifier
spl id: 0dd67012-6278-4c04-ae23-f4872995d773
spl set id: e6e59e84-7bca-46b0-8335-258632d26f77

Reported adverse events (FAERS/openFDA)#

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