SACHEU SPOT ERASER- benzoyl peroxide lotion 
Sacheu Beauty Inc.

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.

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Sacheu Spot Eraser

Drug Facts

Active Ingredients

Benzoyl Peroxide (2.5%)

Purpose

Acne Medication

Uses

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.

Stop use and ask a doctor if irritation becomes severe.

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

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.

imported/distributed by
Gloss Brands Europe
with offices at
Keizersgracht 391a,
Amsterdam, 1016EJ,
Noord Holland, The
Netherlands.

imported/
distributed by Gloss
Brands LLC with offices
at 3381 Robertson
Place, Los Angeles, CA,
90034, USA.

PRINCIPAL DISPLAY PANEL - 15 ml Tube Carton

spot
eraser

blemish drying
lotion

0.5 fl oz / 15 ml

SACHEU

PRINCIPAL DISPLAY PANEL - 15 ml Tube Carton
SACHEU SPOT ERASER 
benzoyl peroxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83101-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE2.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83101-004-0115 mL in 1 TUBE; Type 0: Not a Combination Product11/30/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D11/30/2022
Labeler - Sacheu Beauty Inc. (118824244)
Registrant - Product Society LLC (118666329)
Establishment
NameAddressID/FEIBusiness Operations
Product Society LLC118666329MANUFACTURE(83101-004) , PACK(83101-004) , LABEL(83101-004)

Revised: 12/2022
Document Id: bdd0f399-1c92-4424-ac0a-e0c599a95297
Set id: fb181405-a48e-443a-9924-e9eeb9906a38
Version: 1
Effective Time: 20221205
 
Sacheu Beauty Inc.