Label: MEIJER 3 STEP ACNE SYSTEM- benzoyl peroxide kit
- NDC Code(s): 41250-451-53, 41250-549-61, 41250-567-98
- Packager: Meijer Distribution, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated March 15, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
-
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 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
- Sensitivity Test for a New User: Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated below.
- cover the entire affected area with a thin layer, massaging gently one to two minutes, and rinse thoroughly one to three times daily
- because excessive drying of the skin may occur, start with one application daily, then gradually increase to two to 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, Magnesium Aluminum Silicate, Glyceryl Stearate, PEG-100 Stearate, Sorbitol, Dimethyl Isosorbide, Disodium PEG-12 Dimethicone Sulfosuccinate, Hydrogenated Soybean Oil, Tridecyl Stearate, Neopentyl Glycol Dicaprylate/Dicaprate, Polyethylene Glycol, Cetyl Esters, Anthemis Nobilis Flower Extract, Sodium Hyaluronate, Sodium PCA, Xanthan Gum, Tridecyl Trimellitate, Imidazolidinyl Urea, Methylparaben, Propylparaben, Fragrance
- Active ingredient
- Purpose
- Uses
-
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 eyes, lips, and mouth • avoid contact with hair and dyed fabrics, which may be bleached by this product • skin irritation may occurs, 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
•Sensitivity Test for a New User: Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated below.
- cleanthe 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 to 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
- Label
-
INGREDIENTS AND APPEARANCE
MEIJER 3 STEP ACNE SYSTEM
benzoyl peroxide kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41250-567 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41250-567-98 1 in 1 KIT 02/01/2019 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE 118.2 mL Part 2 1 BOTTLE 59.1 mL Part 1 of 2 STEP 1 RENEWING CLEANSER
benzoyl peroxide lotionProduct Information Item Code (Source) NDC:41250-451 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 2.5 g in 100 mL Inactive Ingredients Ingredient Name Strength HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C) WATER (UNII: 059QF0KO0R) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) SORBITOL (UNII: 506T60A25R) DIMETHYL ISOSORBIDE (UNII: SA6A6V432S) TRIDECYL STEARATE (UNII: A8OE252M6L) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) CETYL ESTERS WAX (UNII: D072FFP9GU) CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG) HYALURONATE SODIUM (UNII: YSE9PPT4TH) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) XANTHAN GUM (UNII: TTV12P4NEE) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) IMIDUREA (UNII: M629807ATL) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41250-451-53 118.2 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 M006 02/01/2019 Part 2 of 2 STEP 3 REPAIRING TREATMENT
benzoyl peroxide lotionProduct Information Item Code (Source) NDC:41250-549 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 2.5 g in 100 mL Inactive Ingredients Ingredient Name Strength POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) WATER (UNII: 059QF0KO0R) DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) CYCLOMETHICONE 4 (UNII: CZ227117JE) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) DIMETHICONE (UNII: 92RU3N3Y1O) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) PANTHENOL (UNII: WV9CM0O67Z) ALLANTOIN (UNII: 344S277G0Z) XANTHAN GUM (UNII: TTV12P4NEE) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) TROLAMINE (UNII: 9O3K93S3TK) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41250-549-61 59.1 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 M006 02/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M006 02/01/2019 Labeler - Meijer Distribution, Inc. (006959555)
