Label: ACNE FREE SENSITIVE SKIN 24 HR ACNE CLEARING SYSTEM- salicylic acid, benzoyl peroxide kit
- NDC Code(s): 80861-007-01, 80861-008-01, 80861-009-01
- Packager: AcneFree LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 27, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Use
- Warnings
- Directions
- Other information
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Inactive ingredients
water, sodium cocoyl isethionate, stearic acid, cocamidopropyl betaine, sodium lauroamphoacetate, disodium laureth sulfosuccinate, glycol distearate, polyacrylate-1 crosspolymer, benzyl alcohol, avena sativa (oat) kernel extract, sodium phytate, zinc PCA, glycerin, sorbic acid, ethyl vanillin, butylene glycol, sea whip extract, aminomethyl propanol
- Questions or comments?
- Drug Facts
- 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. - Other information
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Inactive ingredients
water, ethyl macadamiate, propanediol, glycerin, butylene glycol, polyacrylamide, phenoxyethanol, C13-14 isoparaffin, bisabolol, laureth-7, allantoin, melaleuca alternifolia (tea tree) leaf oil, methylisothiazolinone, sodium hyaluronate, methyl methacrylate/glycol dimethacrylate crosspolymer, sodium hydroxide
- Questions or comments?
- KIT 80861-007-01
- 80861-008-01
- 80861-009-01
-
INGREDIENTS AND APPEARANCE
ACNE FREE SENSITIVE SKIN 24 HR ACNE CLEARING SYSTEM
salicylic acid, benzoyl peroxide kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80861-007 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80861-007-01 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 SALICYLIC ACID ACNE CLEANSER
salicylic acid lotionProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 15 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493) STEARIC ACID (UNII: 4ELV7Z65AP) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) SODIUM LAUROAMPHOACETATE (UNII: SLK428451L) DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E) GLYCOL DISTEARATE (UNII: 13W7MDN21W) BENZYL ALCOHOL (UNII: LKG8494WBH) OAT (UNII: Z6J799EAJK) PHYTATE SODIUM (UNII: 88496G1ERL) ZINC PIDOLATE (UNII: C32PQ86DH4) GLYCERIN (UNII: PDC6A3C0OX) SORBIC ACID (UNII: X045WJ989B) ETHYL VANILLIN (UNII: YC9ST449YJ) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80861-008-01 118 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 SENSITIVE SKIN ACNE
benzoyl peroxide lotionProduct Information Item Code (Source) NDC:80861-009 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 30 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ETHYL MACADAMIATE (UNII: ANA2NCS6V1) PROPANEDIOL (UNII: 5965N8W85T) GLYCERIN (UNII: PDC6A3C0OX) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) PHENOXYETHANOL (UNII: HIE492ZZ3T) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) LEVOMENOL (UNII: 24WE03BX2T) LAURETH-7 (UNII: Z95S6G8201) ALLANTOIN (UNII: 344S277G0Z) TEA TREE OIL (UNII: VIF565UC2G) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) HYALURONATE SODIUM (UNII: YSE9PPT4TH) METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q) SODIUM HYDROXIDE (UNII: 55X04QC32I) GINGER (UNII: C5529G5JPQ) PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80861-009-01 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)
