ACNEFREE DERMATOLOGY INSPIRED CARE SEVERE ACNE 24 HR ACNE CLEARING SYSTEM- benzoyl peroxide kit

AcneFree Dermatology Inspired Care Severe Acne 24 Hr Acne Clearing System by

Drug Labeling and Warnings

AcneFree Dermatology Inspired Care Severe Acne 24 Hr Acne Clearing System by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, Universal Packaging Systems, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Severe Acne 24 HR Acne Clearing System Oil Free Acne Cleanser

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 chidren.

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

Inactive ingredients

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 orcomments

1-888-768-2913

Severe Acne 24 HR Clearing System Witch Hazel Mattifying Toner

Sunburn Alert: This product contains an alpha hydroxy acid (AHA) that may increase your skin’s sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterwards.

CAUTION:

Flammable until dry.

Keep away from flames and heat.

Directions

Use every morning and evening to tone. After cleansing, apply to entire face with a cotton pad, avoiding the eye area. Do not rinse. May also be used on chest and/or back.

Ingredients

water, alcohol denatured, hamamelis virginiana water/witch hazel water, hydrogenated starch hydrolysate, glycerin, polysorbate 20, glycolic acid, sodium hydroxide, citric acid, bisabolol, niacinamide, aloe barbadensis leaf juice powder, panthenol, propylene glycol, disodium EDTA, copper PCA, lactic cid, chamomilla recutita flower extract/matricaria flower extract, pantolactone

Questions orcomments?

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Severe Acne 24 HR Acne Clearing System Retinol Night Cream

Warnings: Avoid direct contact with eyes and lips. If contact occurs, rinse thoroughly with water.

Always apply a broad-spectrum sunscreen while using retinol products and for 1 week after stopping use.

Directions

If you have never used retinol products, begin use two evenings a week, then gradually increase frequency to every other night, and finally once an evening as tolerated. Do not use in association with other products containing retinol.

Ingredients

water, mineral oil, cetearyl alcohol, glycerin, dimethicone, glyceryl stearate, PEG-100 stearate, polysorbate 60, caprylic/capric triglyceride, cetyl alcohol, bisabolol, retinol, sodium hyaluronate, xanthan gum, polysorbate 20, allantoin, C12-15 alkyl benzoate, cetyl palmitate, farnesol, neopentyl glycol dicaprylate/dicaprate, tridecyl stearate, ceramide 3, cetyl triethylmonium dimethiocone PEG 8 succinate, glycine soja (soybean) sterols, tridecyl trimellitater, triethanolamine, disodium EDTA, butylparaben, ethylparaben, propylparaben, isobutylparaben, methylparaben, phenoxyethanol, methylisothiazolinone

Questions or comments?

1-888-768-2913

Severe Acne 24 HR Acne Clearing System MAXIMUM STRENGTH ACNE LOTION

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

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACNEFREE DERMATOLOGY INSPIRED CARE SEVERE ACNE 24 HR ACNE CLEARING SYSTEM 
benzoyl peroxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-044

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-044-04	1 in 1 CARTON; Type 0: Not a Combination Product	08/16/2017

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

ACNEFREE SEVERE OIL FREE ACNE CLEANSER 
benzoyl peroxide cream

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/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
GLYCOLIC ACID (UNII: 0WT12SX38S)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CERAMIDE 3 (UNII: 4370DF050B)
CERAMIDE 6 II (UNII: F1X8L2B00J)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
CHOLESTEROL (UNII: 97C5T2UQ7J)
CERAMIDE 1 (UNII: 5THT33P7X7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		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 final	part333D	08/16/2017

Part 2 of 2

ACNEFREE 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 (UNII: 7FLD91C86K)
ETHYLPARABEN (UNII: 14255EXE39)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		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 final	part333D	08/16/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	08/16/2017

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
Universal Packaging Systems, Inc.		790530976	MANUFACTURE(49967-044)