HUMANE Acne Wash 5 — v2

HUMANE Acne Wash 5

7 Views

Version

v2

Effective date

September 24, 2025

Original packager

Yes

Sections captured

15

Identifiers

Document ID
3f8adb29-f2d8-5c67-e063-6394a90a4b1b
Set ID
9e3f0fa5-9c34-4eff-93a0-606a79847b05
Application numbers
M006
Product NDCs
69919-526
Package NDCs
69919-526-08, 69919-526-16
Original packager NDCs
—

Names & Manufacturers

Brand names
HUMANE Acne Wash 5
Generic names
BENZOYL PEROXIDE
Manufacturer names
Banner 1 LLC
Product types
HUMAN OTC DRUG

Substances & Pharmacology

Substance names
BENZOYL PEROXIDE
Routes
TOPICAL
Pharmacologic class (PE)
—
Pharmacologic class (EPC)
—
Pharmacologic class (CS)
—
Mechanism of action
—

Other identifiers

NUI
—
RxCUI
308696
UNII
W9WZN9A0GM
UPC
0860001867473

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active ingredient Benzoyl Peroxide 5% Purpose Acne Treatment
Do Not Use (1)

Sequence 1

Do not use 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.
Dosage And Administration (1)

Sequence 1

Directions 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 Ingredient (1)

Sequence 1

Inactive ingredients Aqua (Deionized Water), Carbomer, Cocamidopropyl Betaine, Gluconolactone, Sodium Benzoate, Sodium Hydroxide
Indications And Usage (1)

Sequence 1

Use for the treatment of acne.
Keep Out Of Reach Of Children (1)

Sequence 1

Keep out of reach of children: If swallowed, get medical help or contact a Poison Control Center right away.
Package Label Principal Display Panel (2)

Sequence 1

69919-526-08 Outer Label1 Inner Label1

Sequence 2

69919-526-16 Outer Label Inner Label2
Pregnancy Or Breast Feeding (1)

Sequence 1

If pregnant or breastfeeding, ask a health professional before use.
Purpose (1)

Sequence 1

Purpose Acne Treatment
Questions (1)

Sequence 1

Questions? thehumanecompany.com
Spl Product Data Elements (1)

Sequence 1

HUMANE Acne Wash 5 BENZOYL PEROXIDE WATER CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE COCAMIDOPROPYL BETAINE GLUCONOLACTONE SODIUM BENZOATE SODIUM HYDROXIDE BENZOYL PEROXIDE BENZOYL PEROXIDE
Spl Unclassified Section (1)

Sequence 1

Drug Facts
Stop Use (1)

Sequence 1

Stop use and ask a doctor if excessive irritation occurs.
Warnings (1)

Sequence 1

Warnings For external use only. Do not use 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 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 if excessive irritation occurs. Keep out of reach of children: If swallowed, get medical help or contact a Poison Control Center right away. If pregnant or breastfeeding, ask a health professional before use.
When Using (1)

Sequence 1

When using this product 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.

OpenFDA raw payload

{'application_number': ['M006'],
 'brand_name': ['HUMANE Acne Wash 5'],
 'generic_name': ['BENZOYL PEROXIDE'],
 'is_original_packager': [True],
 'manufacturer_name': ['Banner 1 LLC'],
 'package_ndc': ['69919-526-08', '69919-526-16'],
 'product_ndc': ['69919-526'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['TOPICAL'],
 'rxcui': ['308696'],
 'spl_id': ['3f8adb29-f2d8-5c67-e063-6394a90a4b1b'],
 'spl_set_id': ['9e3f0fa5-9c34-4eff-93a0-606a79847b05'],
 'substance_name': ['BENZOYL PEROXIDE'],
 'unii': ['W9WZN9A0GM'],
 'upc': ['0860001867473']}