ACNE FREE SEVERE ACNE 24 HR ACNE CLEARING SYSTEM- benzoyl peroxide kit

Acne Free SEVERE ACNE 24 HR Acne Clearing System by

Drug Labeling and Warnings

Acne Free SEVERE ACNE 24 HR Acne Clearing System by is a Otc medication manufactured, distributed, or labeled by AcneFree, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• use every morning and evening
• apply a dime-size amount to damp skin and gently massage, avoiding the eye area
• rinse well
• use wash on entire affected area one to two times daily
• because excessive drying of the skin may occur, start with washing once daily, then gradually increase to two times daily if needed or as directed by a doctor
• if bothersome dryness or peeling occurs, reduce cleansing 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.
• may be used on chest or back

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

80861-004-01

80861-011-01

INGREDIENTS AND APPEARANCE

ACNE FREE SEVERE ACNE 24 HR ACNE CLEARING SYSTEM 
benzoyl peroxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80861-010

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80861-010-01	1 in 1 KIT	12/01/2017

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE	118 mL
Part 2	1 BOTTLE	59 mL

Part 1 of 2

OIL FREE ACNE CLEANSER 
benzoyl peroxide gel

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	25 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80861-004-01	118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	12/01/2017

Part 2 of 2

MAXIMUM STRENGTH ACNE 
benzoyl peroxide lotion

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80861-011-01	59 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	12/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	12/01/2017

Labeler - AcneFree, LLC (122237140)