5 Acne Med

Manufacturer
Face Reality, Inc.
Effective date
2024-06-05
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:13:22

Label at a glance#

Product5 Acne Med
Active ingredientBENZOYL PEROXIDE
Label structure8 sections

Dosage and administration

clean the skin thoroughly before applying this product cover the entire affected area with a thin layer one or 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 ...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzoyl Peroxide 5%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Use

INDICATIONS & USAGE SECTION

  • for the treatment of acne

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • if you have very sensitive skin
  • if you 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, burning, itching, peeling, or possibly 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 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 or 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.

Other information

SPL UNCLASSIFIED SECTION

  • Store at room temperature. Keep away from heat or direct sunlight.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Purified Water, Glycerin, Propylene Glycol, Carbomer, Sodium Hydroxide.

Questions or Comments?

OTC - QUESTIONS SECTION

1-866-477-3077

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle3Bottle3Tube2Tube2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308694benzoyl peroxide 5 % Topical GelPSN3
308694benzoyl peroxide 0.05 MG/MG Topical GelSCD3
308694benzoyl peroxide 5 % Topical GelSY3

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70707-155-155 Acne Med1 in 1 CARTONGEL13
70707-155-155 Acne Med44 mL in 1 TUBEGEL443

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70707-1555 ACNE MED (BENZOYL PEROXIDE) GEL [FACE REALITY, INC.]3Legacy NDC, 2 package rows20240606_d860756d-d74a-4d50-8af0-4ccbcc756a88.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70707-15570707-155-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 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
1a270c93-8d91-38ba-e063-6394a90a25ead860756d-d74a-4d50-8af0-4ccbcc756a882024-06-05WarningsExact identifier
spl id: 1a270c93-8d91-38ba-e063-6394a90a25ea
spl set id: d860756d-d74a-4d50-8af0-4ccbcc756a88

Reported adverse events (FAERS/openFDA)#

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