Benzoyl Peroxide Gel

Manufacturer
GERITREX LLC
Effective date
2016-08-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:46:48

Label at a glance#

ProductBenzoyl Peroxide
Active ingredientBENZOYL PEROXIDE
Label structure9 sections

Dosage and administration

Shake well, wet face, apply to hands, add water, work into a lather, and massage gently onto face. Rinse thoroughly and pat dry use 2 to 3 times daily or as directed by a doctor if bothersome dryness of peeling occurs, reduce application to once a day or every other day if going outside use sunscreen. After washing and drying face follow directions in the sunscreen labeling if irritation or sensitivity develops, d...

Storage and handling

Store at room temperature 15°-30°C (59°-86°F)

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient Purpose

Benzoyl Peroxide 10% Acne Treatment

Use

OTC - PURPOSE SECTION

For the treatment of acne

Directions

INDICATIONS & USAGE SECTION

Shake well, wet face, apply to hands, add water, work into a lather, and massage gently onto face. Rinse thoroughly and pat dry

use 2 to 3 times daily or as directed by a doctor if bothersome dryness of peeling occurs, reduce application to once a day or every other

day if going outside use sunscreen. After washing and drying face follow directions in the sunscreen labeling if irritation or sensitivity develops,

discontinue use of both products and consult a doctor

Warnings

WARNINGS SECTION

For external use only

Do not use if you have very sensitive skin of if you are sensitive to benzoyl peroxide

When using this product avoid unnecessary sun exposure and use a sunscreen using other topical acne drugs at the same time or right

after use of this product may increase dryness or irritation of the skin. If this occurs, only one drug should be used unless directed by a

doctor. Irritation may develop, such as redness, burning, itching, peeling, or possibly swelling more frequent use or higher concentraions may

aggravate such irritation: mild irritation may be reduced by using the product less frequently or in lower concnetraion. Keep away from eyes,

lips, mouth It may bleach hair of dye fabrics

Stop use and ask a doctor if irritaion becomes severe and continue.

Inactive Ingrdients

INACTIVE INGREDIENT SECTION

Purified water, Carbomer, Cetearth 20 cetearyl alcohol, DMDM Hydantoin, EDTA, Peg 40 Hydrogenated castor oil, Ethyl Glycol Mono Stearate, Mineral Oil, Methyl and Propyl Paraben, Peg 200 dilurate, Glycerin, silicon oil, Stearic acid, stearyl alcohol, TEA, Magnesium aluminium silicate powder

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of chlidren. If swallowed, get medical help or contact Poison Control Center right away

STORAGE AND HANDLING SECTION

Store at room temperature 15°-30°C (59°-86°F)

DOSAGE & ADMINISTRATION SECTION

Use 2 to 3 times daily or as directed by a doctor.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label of TubeLabel of Tube

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
486131benzoyl peroxide 10 % Topical GelPSN2
486131benzoyl peroxide 0.1 MG/MG Topical GelSCD2
486131benzoyl peroxide 10 % Topical GelSY2

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
54162-019-022020-01-31C16284748780-19d75b9d0-cfb5-f424-e053-dadaa90a57ceBenzoyl Peroxide Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54162-019-02Benzoyl Peroxide56 g in 1 TUBEGEL562

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54162-019BENZOYL PEROXIDE GEL [GERITREX LLC]2Legacy NDC, 1 package rows20160816_d117caf6-d1e7-428f-8db5-eaf101c35356.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54162-019-02GM - Gram54162-0196ced25e3-8f04-416f-a653-42f372258e3512014-09-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BENZOYL PEROXIDEACTIVE INGREDIENTW9WZN9A0GM1
BENZOYL PEROXIDEACTIVE MOIETYW9WZN9A0GM1
CARBOMER 940INACTIVE INGREDIENT4Q93RCW27E1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN1
DIETHYLENE GLYCOL DISTEARATEINACTIVE INGREDIENT617Q4OD69O1
DISODIUM HEDTAINACTIVE INGREDIENTKME849MC7A1
DMDM HYDANTOININACTIVE INGREDIENTBYR0546TOW1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NC1
MAGNESIUM DISODIUM EDTAINACTIVE INGREDIENTNDT563S5VZ1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGP1
PEG-200 DILAURATEINACTIVE INGREDIENTTWV5J70L881
PEG-40 CASTOR OILINACTIVE INGREDIENT4ERD2076EF1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH1
SILICONINACTIVE INGREDIENTZ4152N8IUI1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1Y1
TRIETHANOLAMINE LAURYL SULFATEINACTIVE INGREDIENTE8458C1KAA1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54162-01954162-019-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 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 · 346 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCAPSULE / ORAL1 mgExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSUPPOSITORY / VAGINALNAExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHLIQUID / ORAL2 mgExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION / SOFT TISSUE0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APCAPSULE / ORAL90 mgExact identifier — unii candidate
26 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRAMUSCULAR450 mgExact identifier — unii candidate
75 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APCREAM / TOPICAL190 mgExact identifier — unii candidate
26 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TDROPS / OPHTHALMIC0.01 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCSUSPENSION / ORAL5000 mg/5mlExact identifier — unii candidate
17 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, COATED / ORAL1.5 mgExact identifier — unii candidate
30 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHLIQUID / TOPICAL0.1 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
STEARYL ALCOHOLSTEARYL ALCOHOL2KR89I4H1YSUSPENSION / TOPICAL2.01 %w/wExact identifier — unii candidate
12 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSPRAY / NASAL0.2 mgExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS15 mgExact identifier — unii candidate
79 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / TRANSDERMAL306.2 mgExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHTABLET / ORAL0.2 mgExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TGEL / VAGINAL8 mgExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TDROPS / NASAL26 mgExact identifier — unii candidate
79 equally ranked IID candidates
STEARYL ALCOHOLSTEARYL ALCOHOL2KR89I4H1YSUPPOSITORY / VAGINAL8.5 mgExact identifier — unii candidate
12 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHFILM / BUCCAL0.22 mgExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHDROPS / AURICULAR (OTIC)NAExact identifier — unii candidate
68 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUPPOSITORY / RECTAL440 mgExact identifier — unii candidate
75 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION, CONCENTRATE / ORAL1 mg/1mlExact identifier — unii candidate
79 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APAEROSOL, FOAM / VAGINAL4 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APCREAM / VAGINAL1088 mgExact identifier — unii candidate
26 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNTABLET, COATED / ORAL0.25 mgExact identifier — unii candidate
20 equally ranked IID candidates
STEARYL ALCOHOLSTEARYL ALCOHOL2KR89I4H1YLOTION / TOPICAL1140 mgExact identifier — unii candidate
12 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / ORAL346 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR0.4 mgExact identifier — unii candidate
68 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSYSTEM / TOPICAL654.36 mgExact identifier — unii candidate
30 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCOINTMENT / VAGINAL231 mgExact identifier — unii candidate
17 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, CHEWABLE / ORAL12 mgExact identifier — unii candidate
75 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCPOWDER, FOR SUSPENSION / ORALNAExact identifier — unii candidate
17 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS0.8 mgExact identifier — unii candidate
68 equally ranked IID candidates
CARBOMER 940CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27ELOTION / TOPICAL300 mgExact identifier — unii candidate
9 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION / INTRAMUSCULAR6 mgExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TJELLY / TOPICAL420 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSUSPENSION / AURICULAR (OTIC)NAExact identifier — unii candidate
68 equally ranked IID candidates
SILICONSILICONZ4152N8IUIPOWDER, FOR SUSPENSION / ORALNAExact identifier — unii candidate
5 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APSHAMPOO / TOPICAL9.7 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TPOWDER, FOR SOLUTION / ORAL126 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHTABLET, EXTENDED RELEASE / ORAL0.12 mgExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION, SUSPENSION / INTRAMUSCULAR0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
CARBOMER 940CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EGEL, METERED / TRANSDERMAL50 mgExact identifier — unii candidate
9 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHEMULSION / TOPICAL0.06 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / NASAL250 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHOINTMENT / TOPICAL0.2 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNSUSPENSION / AURICULAR (OTIC)1 %w/vExact identifier — unii candidate
20 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION, SUSPENSION / SUBCUTANEOUS0.16 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION, CONCENTRATE / ORAL200 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APLOTION / TOPICAL80 mgExact identifier — unii candidate
26 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSUSPENSION / RECTAL271 mgExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TPOWDER, FOR SUSPENSION / ORAL75 mgExact identifier — unii candidate
79 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUPPOSITORY / RECTALNAExact identifier — unii candidate
30 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXELIXIR / ORAL5621 mgExact identifier — unii candidate
75 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCCREAM / TOPICAL3 %w/wExact identifier — unii candidate
17 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUSPENSION / TOPICAL82 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / INTRA-ARTICULAR0.24 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUSPENSION / OPHTHALMIC0.1 %w/wExact identifier — unii candidate
30 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
79486277-a36d-46e7-92c0-27741ad8b697d117caf6-d1e7-428f-8db5-eaf101c353562016-08-10WarningsExact identifier
spl id: 79486277-a36d-46e7-92c0-27741ad8b697
spl set id: d117caf6-d1e7-428f-8db5-eaf101c35356

Reported adverse events (FAERS/openFDA)#

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