ACNEFREE DERMATOLOGY INSPIRED CARE OIL FREE 24 HR ACNE CLEARING SYSTEM- benzoyl peroxide 
L'Oreal USA Products Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Oil Free 24 HR Acne Clearing System ACNE LOTION

Drug Facts

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.

Directons

  • 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

Oil-Free 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 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

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 or comments?

1-888-768-2913

Oil Free 24 HR Acne 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 denat., 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 acid, chamomilla recutita flower extract/matricaria flower extract, pantolactone

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ACNEFREE DERMATOLOGY INSPIRED CARE OIL FREE 24 HR ACNE CLEARING SYSTEM 
benzoyl peroxide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-716
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49967-716-031 in 1 CARTON; Type 0: Not a Combination Product08/18/201707/31/2021
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 59 mL
Part 21 BOTTLE 118 mL
Part 1 of 2
OIL FREE 24 HOUR CLEARING SYSTEM 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 PEROXIDE37 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GLYCERIN (UNII: PDC6A3C0OX)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
CERAMIDE 3 (UNII: 4370DF050B)  
CERAMIDE 6 II (UNII: F1X8L2B00J)  
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
159 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D08/18/201707/31/2021
Part 2 of 2
OIL FREE 24 HOUR CLEARING SYSTEM OIL FREE ACNE CLEANSER 
benzoyl peroxide liquid
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/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)  
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
GLYCOLIC ACID (UNII: 0WT12SX38S)  
CERAMIDE 3 (UNII: 4370DF050B)  
CERAMIDE 6 II (UNII: F1X8L2B00J)  
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D08/18/201707/31/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D08/18/201707/31/2021
Labeler - L'Oreal USA Products Inc (002136794)
Establishment
NameAddressID/FEIBusiness Operations
Universal Packaging Systems, Inc.177711082MANUFACTURE(49967-716)

Revised: 7/2021
 
L'Oreal USA Products Inc