Label: ACNE FREE FREE 24 HR ACNE CLEARING SYSTEM- benzoyl peroxide kit
- NDC Code(s): 80861-004-01, 80861-005-01, 80861-006-01
- Packager: AcneFree, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 18, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Use
-
Warnings
For external use only
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.
-
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?
- Active ingredient
- Use
-
Warnings
For external use only
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. -
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
- Questions or comments?
- KIT 80861-006-01
- 80861-004-01
- 80861-005-01
-
INGREDIENTS AND APPEARANCE
ACNE FREE FREE 24 HR ACNE CLEARING SYSTEM
benzoyl peroxide kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80861-006 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80861-006-01 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 gelProduct 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 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 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 OIL FREE ACNE
benzoyl peroxide lotionProduct 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 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:80861-005-01 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)
