Spot On Treatment

Manufacturer
SGII, INC | 220 LABORATORIES INC
Effective date
2021-12-07
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:45:28

Label at a glance#

ProductSpot On Treatment
Active ingredientBENZOYL PEROXIDE
Label structure11 sections

Indications and uses

For the treatment of Acne

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 outsid...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzoyl Peroxide 10%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Uses

INDICATIONS & USAGE SECTION

For the treatment of Acne

Warnings

WARNINGS SECTION

For External Use Only

Keep Out Of Eyes

OTC - WHEN USING SECTION

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. • 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

OTC - DO NOT USE SECTION

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

OTC - STOP USE SECTION

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.

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

Allantoin, Aloe Vera (Aloe Barbadensis) Leaf Juice, Bisabolol, Caprylyl Glycol, Carbomer, C13-14 Isoalkane, Diethylhexyl Sodium Sulfosuccinate, Dimethicone, Dimethyl Isosorbide, Ethylhexylglycerin, Ginger (Zingiber Officinale) Root Extract, Hexylene Glycol, Laureth-7, Menthoxypropanediol, Panthenol, PEG-40 Stearate, Phenoxyethanol, Polyacrylamide, Propanediol, Silica, Sodium Citrate, Sodium Hydroxide, Sorbitan Stearate, Water/Aqua/Eau, Xanthan Gum.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SeneGence

Spot-On

10% Benzoyl Peroxide

Acne Treatment

SenePlex+

15mL/0.5 fl oz U.S.

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
106310benzoyl peroxide 10 % Topical LotionPSN3
106310benzoyl peroxide 100 MG/ML Topical LotionSCD3
106310benzoyl peroxide 10 % Topical LotionSY3

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
72644-636-012024-07-30C16284748780-11030e365-174d-111a-e063-dadaa90a10e2Spot On Treatment
72644-636-012024-01-30C16284748780-11030e365-174d-111a-e063-dadaa90a10e2Spot On Treatment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72644-636-01Spot On Treatment15 g in 1 BOTTLELOTION153

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72644-636SPOT ON TREATMENT (BENZYL PEROXIDE) LOTION [SGII, INC]3Legacy NDC, 1 package rows20211208_af7500db-4445-36f6-e053-2995a90a8754.zip

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72644-63672644-636-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Source Document#

Source XML

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
d2948dc8-0769-7dcc-e053-2995a90a10d9af7500db-4445-36f6-e053-2995a90a87542021-12-07WarningsExact identifier
spl id: d2948dc8-0769-7dcc-e053-2995a90a10d9
spl set id: af7500db-4445-36f6-e053-2995a90a8754

Reported adverse events (FAERS/openFDA)#

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