FDA.reportPublic FDA data

HUMANE Maximum Strength Acne Wash 10 Benzoyl Peroxide

Manufacturer
Banner 1 LLC
Effective date
2025-09-24
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:14:47

Label at a glance#

ProductHUMANE Maximum Strength Acne Wash 10 Benzoyl Peroxide
Active ingredientBENZOYL PEROXIDE
Label structure8 sections

Dosage and administration

New User: Test 1-2 small affected areas for sensitivity for 3 days. If no discomfort occurs, apply acne wash and gently massage into damp skin. Wait 1-3 minutes for wash to absorb. Rinse thoroughly.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzoyl Peroxide 10%

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 are sensitive to benzoyl peroxide or have very sensitive skin.
  • Using other topical acne drugs at the same time or right after use of this product may increase dryness, redness or irritation of the skin.
  • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to twice daily if needed. If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

When using this product

OTC - WHEN USING SECTION

  • Avoid contact with and near eyes. If contact occurs, flush thoroughly with water. Keep away from lips and mouth.
  • Avoid unnecessary sun exposure and use a sunscreen.
  • Avoid product contact with hair and dyed fabrics, including carpets and clothing which may be bleached by this product.

Stop use and ask a doctor

OTC - STOP USE SECTION

if excessive irritation occurs.

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.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Directions

DOSAGE & ADMINISTRATION SECTION

New User: Test 1-2 small affected areas for sensitivity for 3 days. If no discomfort occurs, apply acne wash and gently massage into damp skin. Wait 1-3 minutes for wash to absorb. Rinse thoroughly.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua (Deionized Water), Carbomer, Cocamidopropyl Betaine, Gluconolactone, Sodium Benzoate, Sodium Hydroxide

Questions?

OTC - QUESTIONS SECTION

thehumanecompany.com

69919-527-08

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Label3Outer Label3Inner Label3Inner Label3

69919-527-16

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

16ozneww16ozneww

16441644

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
142034benzoyl peroxide 10 % Medicated Liquid SoapPSN2
142034benzoyl peroxide 100 MG/ML Medicated Liquid SoapSCD2
142034benzoyl peroxide 10 % Medicated Liquid SoapSY2

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
69919-527-08HUMANE Maximum Strength Acne Wash 10 Benzoyl Peroxide237 mL in 1 BOTTLELIQUID2372
69919-527-08HUMANE Maximum Strength Acne Wash 10 Benzoyl Peroxide1 in 1 BOXLIQUID12
69919-527-16HUMANE Maximum Strength Acne Wash 10 Benzoyl Peroxide473 mL in 1 BOTTLELIQUID4732
69919-527-16HUMANE Maximum Strength Acne Wash 10 Benzoyl Peroxide1 in 1 BOXLIQUID12

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69919-52769919-527-08, 69919-527-16

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
GLUCONOLACTONEWQ29KQ9POTIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM HYDROXIDE55X04QC32IIACT
BENZOYL PEROXIDEW9WZN9A0GMACTIB

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
HUMANE Maximum Strength Acne Wash 10 Benzoyl PeroxideBENZOYL PEROXIDEBanner 1 LLCf5b4d25c-af21-4698-bfa3-732ca19d40f52025-09-24WarningsExact identifier
ndc (package): 69919-527-16
ndc (package): 69919-527-08
ndc (product): 69919-527
ndc11 (package): 69919052708
ndc11 (package): 69919052716
spl id: 3f8ace08-ef21-0568-e063-6294a90a0e88
spl set id: f5b4d25c-af21-4698-bfa3-732ca19d40f5

Reported adverse events (FAERS/openFDA)#

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