Label: SPOT ON TREATMENT- benzyl peroxide lotion
- NDC Code(s): 72644-636-01
- Packager: SGII, 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 December 7, 2021
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
- Warnings
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WHEN USING
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
- DO NOT USE
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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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.
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Inactive Ingredients
Allantoin, Aloe Vera (Aloe Barbadensis) Leaf Juice, Bisabolol, Caprylyl Glycol, Carbomer, C13-14 Isoalkane, Diethylhexyl Sodium Sulfosuccinate, Dimethicone, Dimethyl Isosorbide, Ethylhexylglycerin, Ginger (Zingiber Officinale) Root Extract, Hexylene Glycol, Laureth-7, Menthoxypropanediol, Panthenol, PEG-40 Stearate, Phenoxyethanol, Polyacrylamide, Propanediol, Silica, Sodium Citrate, Sodium Hydroxide, Sorbitan Stearate, Water/Aqua/Eau, Xanthan Gum.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SPOT ON TREATMENT
benzyl peroxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72644-636 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 10 g in 100 g Inactive Ingredients Ingredient Name Strength PEG-40 STEARATE (UNII: ECU18C66Q7) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) DIMETHICONE (UNII: 92RU3N3Y1O) LAURETH-7 (UNII: Z95S6G8201) ALOE VERA LEAF (UNII: ZY81Z83H0X) PROPANEDIOL (UNII: 5965N8W85T) DIMETHYL ISOSORBIDE (UNII: SA6A6V432S) SODIUM CITRATE (UNII: 1Q73Q2JULR) ALLANTOIN (UNII: 344S277G0Z) LEVOMENOL (UNII: 24WE03BX2T) DOCUSATE SODIUM (UNII: F05Q2T2JA0) PANTHENOL (UNII: WV9CM0O67Z) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GINGER (UNII: C5529G5JPQ) POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) 3-((L-MENTHYL)OXY)PROPANE-1,2-DIOL (UNII: KD6TZ2QICH) PHENOXYETHANOL (UNII: HIE492ZZ3T) XANTHAN GUM (UNII: TTV12P4NEE) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) HEXYLENE GLYCOL (UNII: KEH0A3F75J) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72644-636-01 15 g in 1 BOTTLE; Type 0: Not a Combination Product 09/16/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 09/16/2020 Labeler - SGII, INC (070096792) Establishment Name Address ID/FEI Business Operations 220 LABORATORIES INC 783247950 manufacture(72644-636)
