Sacheu Spot Eraser
FDA Label NDC 83101-004

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sacheu Beauty Inc. for the product Sacheu Spot Eraser (NDC 83101-004). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredients, purpose, uses, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

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.

Active Ingredients

Benzoyl Peroxide (2.5%)

Purpose

Acne Medication

Uses

  • For the treatment of acne

Otc - Do Not Use

For external use only. Do not use if you have very sensitive skin or are sensitive to benzoyl peroxide.

Otc - 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.

Otc - Stop Use

Stop use and ask a doctor if irritation becomes severe.

Otc - Keep Out Of Reach Of Children

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.

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)

Principal Display Panel (15 ml Tube Carton)

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