ACNE FREE FREE 24 HR ACNE CLEARING SYSTEM- benzoyl peroxide 
AcneFree, LLC

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Acne Free Oil Free 24 HR Acne Clearing System KIT

Active ingredient

Benzoyl peroxide 2.5%

Purpose

Acne treatment

Use

for the treatment of acne

Warnings

For external use only

Do not use

if you

• have very sensitive skin
• are sensitive to benzoyl peroxide

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.

Stop use and ask a doctor if

skin irritation becomes severe

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Questions or comments?

water, glycerin, propylene glycol, cocamidopropyl hydroxysultaine, sodium C14-16 olefin sulfonate, xanthan gum, citric acid, potassium hydroxide, methyl methacrylate/glycol dimethacrylate crosspolymer, sodium lauroyl lactylate, glycolic acid, ceramide NP, ceramide AP, phytosphingosine, cholesterol, carbomer, ceramide EOP

Questions or comments?

1-888-768-2913

Active ingredient

Benzoyl peroxide 3.7%

Purpose

Acne treatment

Use

for the treatment of acne

Warnings

For external use only

Do not use

if you

• have very sensitive skin
• are sensitive to benzoyl peroxide

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.

Stop use and ask a doctor if

skin irritation becomes severe

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• 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

water, propylene glycol, glycerin, carbomer, potassium hydroxide, polysorbate 80, methyl methacrylate/glycol dimethacrylate crosspolymer, disodium EDTA, sodium lauroyl lactylate, ceramide NP, ceramide AP, phytosphingosine, cholesterol, xanthan gum, ceramide EOP

Questions or comments?

1-888-768-2913

KIT 80861-006-01

Kit

80861-004-01

2.5_BPO Cleanser

80861-005-01

5_BPO lotion

ACNE FREE FREE 24 HR ACNE CLEARING SYSTEM 
benzoyl peroxide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80861-006
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80861-006-011 in 1 KIT12/01/2017
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 118 mL
Part 21 BOTTLE 59 mL
Part 1 of 2
OIL FREE ACNE CLEANSER 
benzoyl peroxide gel
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CERAMIDE NG (UNII: C04977SRJ5)  
AVENA SATIVA (OAT) KERNEL EXTRACT (UNII: Z6J799EAJK)  
NIACINAMIDE (UNII: 25X51I8RD4)  
WATER (UNII: 059QF0KO0R)  
CETEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERYL STEARATE (UNII: 230OU9XXE4)  
COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)  
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CARBOMER (UNII: 0A5MM307FC)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
CETEARETH-20 (UNII: YRC528SWUY)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCOLIC ACID (UNII: 0WT12SX38S)  
CALCIUM DISODIUM EDTA (UNII: 8U5D034955)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80861-004-01118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00612/01/2017
Part 2 of 2
OIL FREE ACNE 
benzoyl peroxide lotion
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERETH-26 (UNII: NNE56F2N14)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
GLYCERIN (UNII: PDC6A3C0OX)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
CALCIUM DISODIUM EDTA (UNII: 8U5D034955)  
GLYCOLIC ACID (UNII: 0WT12SX38S)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SODIUM HYALURONATE (UNII: YSE9PPT4TH)  
PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER (UNII: 788QAG3W8A)  
NIACINAMIDE (UNII: 25X51I8RD4)  
CERAMIDE NG (UNII: C04977SRJ5)  
AVENA SATIVA (OAT) KERNEL EXTRACT (UNII: Z6J799EAJK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80861-005-0159 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00612/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00612/01/2017
Labeler - AcneFree, LLC (122237140)

Revised: 11/2024
Document Id: 273418a3-9582-a4f4-e063-6394a90a9545
Set id: c939847a-72eb-96fa-e053-2a95a90a4f9c
Version: 6
Effective Time: 20241118
 
AcneFree, LLC