Label: SACHEU SPOT ERASER- benzoyl peroxide lotion
- NDC Code(s): 83101-004-01
- Packager: Sacheu Beauty 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 5, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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- Active Ingredients
- Purpose
- Uses
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Warnings
For external use only. Do not use if you have very sensitive skin or are sensitive to benzoyl peroxide.
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.
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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 on 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
Water (Aqua), Kaolin, Bentonite, Propylene Glycol, Hydroxyethyl Behenamidopropyl Dimonium Chloride, Butyrospermum Parkii (Shea) Butter Extract, Magnesium Aluminum Silicate, Euphorbia Cerifera (Candelilla) Wax, Xanthan Gum, Allantoin, Bisabolol, Caprylyl Glycol, Sodium Citrate, Phenoxyethanol, Ethylhexylglycerin.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 15 ml Tube Carton
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INGREDIENTS AND APPEARANCE
SACHEU SPOT ERASER
benzoyl peroxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83101-004 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 WATER (UNII: 059QF0KO0R) 65.0188 g in 100 mL KAOLIN (UNII: 24H4NWX5CO) 19 g in 100 mL BENTONITE (UNII: A3N5ZCN45C) 6 g in 100 mL PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 3 g in 100 mL HYDROXYETHYL BEHENAMIDOPROPYL DIMONIUM CHLORIDE (UNII: 9CO8OUL4TH) 1.32 g in 100 mL SHEA BUTTER (UNII: K49155WL9Y) 0.88 g in 100 mL MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) 0.6 g in 100 mL CANDELILLA WAX (UNII: WL0328HX19) 0.55 g in 100 mL XANTHAN GUM (UNII: TTV12P4NEE) 0.13 g in 100 mL ALLANTOIN (UNII: 344S277G0Z) 0.0003 g in 100 mL LEVOMENOL (UNII: 24WE03BX2T) 0.0003 g in 100 mL CAPRYLYL GLYCOL (UNII: 00YIU5438U) 0.0003 g in 100 mL SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) 0.0003 g in 100 mL PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.86 g in 100 mL ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) 0.14 g in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83101-004-01 15 mL in 1 TUBE; Type 0: Not a Combination Product 11/30/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part333D 11/30/2022 Labeler - Sacheu Beauty Inc. (118824244) Registrant - Product Society LLC (118666329) Establishment Name Address ID/FEI Business Operations Product Society LLC 118666329 MANUFACTURE(83101-004) , PACK(83101-004) , LABEL(83101-004)
