Label: SOLIMO REPAIRING TREATMENT FOR ACNE PRONE SKIN- benzoyl peroxide liquid
- NDC Code(s): 72288-525-01, 72288-525-02
- Packager: Amazon.com Services LLC
- Category: HUMAN OTC DRUG LABEL
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 June 22, 2020
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient
For external use only.
When using this product:
- do not use this product more than three times per day.
- skin irritation and dryness are 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.
- Sensitivity Test for a New User: Apply product sparinglyto one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated below.
- cleanse 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
- Package Labeling:1oz
- Package Labeling:2oz
INGREDIENTS AND APPEARANCE
SOLIMO REPAIRING TREATMENT FOR ACNE PRONE SKIN
benzoyl peroxide liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72288-525 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) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) CYCLOMETHICONE 4 (UNII: CZ227117JE) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) DIMETHICONE (UNII: 92RU3N3Y1O) XANTHAN GUM (UNII: TTV12P4NEE) PEG-100 STEARATE (UNII: YD01N1999R) ALLANTOIN (UNII: 344S277G0Z) PANTHENOL (UNII: WV9CM0O67Z) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) IMIDUREA (UNII: M629807ATL) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) SODIUM HYDROXIDE (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72288-525-01 29 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/30/2020 2 NDC:72288-525-02 59 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/30/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 07/30/2020 Labeler - Amazon.com Services LLC (128990418) Establishment Name Address ID/FEI Business Operations Filltech USA, LLC 926433855 manufacture(72288-525)