10% Benzoyl Peroxide Acne Medicated Gel 229.001/229AC-AD

Manufacturer
Vi-Jon, LLC | Remar Inc.
Effective date
2022-01-11
Label type
HUMAN OTC DRUG LABEL
Version
17
Source
legacy-cache
Hydrated at
2026-08-01 22:18:04

Label at a glance#

ProductAcne Treatment
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 daily application to once a day or every other day if going outside, ...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzoyl peroxide 10%

Purpose

OTC - PURPOSE SECTION

Acne medication

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 very 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
  • avoid unnecessary sun exposure and use a sunscreen
  • avoid contact with 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, buring, itching, peeling or posible 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

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 daily 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

carbomer, disodium EDTA, hydroxypropyl methylcellulose, laureth-4, sodium hydroxide, water

SPL UNCLASSIFIED SECTION

manufactured by Vi-Jon, LLC

St. Louis, MO 63114

principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

mountain falls

Compare to Clean & Clear*

for treat of acne

dermatologist tested

10% BENZOYL PEROXIDE acne treatment

maximum strength

NET WT 1 OZ (28 g)

image descriptionimage description

Products#

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DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0869-02290869-0229-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Source Document#

Source XML · Source PDF

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
ed8c670b-73f5-4d73-98c3-06234f5566854116631a-1de2-44ab-8cff-7efc6bcbe1fe2023-11-13WarningsExact identifier
spl set id: 4116631a-1de2-44ab-8cff-7efc6bcbe1fe

Reported adverse events (FAERS/openFDA)#

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