SACHEU SPOT ERASER- benzoyl peroxide lotion

Sacheu Spot Eraser by

Drug Labeling and Warnings

Sacheu Spot Eraser by is a Otc medication manufactured, distributed, or labeled by Sacheu Beauty Inc., Product Society LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Benzoyl Peroxide (2.5%)

Purpose

Acne Medication

Uses

• For the treatment of acne

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

• 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.

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

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

INGREDIENTS AND APPEARANCE

SACHEU SPOT ERASER 
benzoyl peroxide lotion

Product 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)