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

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Acne Free SEVERE ACNE 24 HR Acne Clearing System KIT

Drug Facts

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

Drug Facts

Active ingredient

Benzoyl peroxide 10%

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, butylene glycol, C12-15 alkyl benzoate, glycerin, glyceryl stearate, PEG-100 stearate, cetearyl alcohol, phenoxyethanol, hydroxypropyl starch phosphate, polysorbate 60, dimethicone, xanthan gum, cetyl alcohol, bisabolol, tetrasodium EDTA, ethylhexylglycerin,  methylisothiazolinone, benzalkonium chloride, sea whip extract, zingiber officinale (ginger) root extract, chamomilla recutita (matricaria) flower extract, alcohol, leuconostoc/radish root ferment filtrate, methylparaben, disodium EDTA, ethylparaben, methyl methacrylate/glycol  dimethacrylate crosspolymer

Questions or comments?

1-888-768-2913

KIT 80861-010-01

Kit02Kit03

80861-004-01

Label08

80861-011-01

Label09

ACNE FREE SEVERE ACNE 24 HR ACNE CLEARING SYSTEM 
benzoyl peroxide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80861-010
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80861-010-011 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
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)  
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
METHYL METHACRYLATE (UNII: 196OC77688)  
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
GLYCOLIC ACID (UNII: 0WT12SX38S)  
CERAMIDE NP (UNII: 4370DF050B)  
CERAMIDE AP (UNII: F1X8L2B00J)  
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
CERAMIDE 1 (UNII: 5THT33P7X7)  
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
MAXIMUM STRENGTH 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 PEROXIDE100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
LEVOMENOL (UNII: 24WE03BX2T)  
EDETATE SODIUM (UNII: MP1J8420LU)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5)  
GINGER (UNII: C5529G5JPQ)  
CHAMOMILE (UNII: FGL3685T2X)  
ALCOHOL (UNII: 3K9958V90M)  
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
ETHYLPARABEN (UNII: 14255EXE39)  
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80861-011-0159 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: 12/2023
Document Id: 0d8097f5-9743-123c-e063-6394a90aedd1
Set id: c939681e-ea93-31ce-e053-2a95a90a8c70
Version: 4
Effective Time: 20231227
 
AcneFree, LLC