Asepxia Baking Soda Acne Bar Soap
FDA Label NDC 50066-810

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Genomma Lab Usa for the product Asepxia Baking Soda Acne Bar (NDC 50066-810). 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 ingredient, purpose, uses, warnings, 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

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Drug Facts

Distributed by: Genomma Lab USA Inc., Houston, TX 77098

Active Ingredient

Salicylic Acid, 1.8%

Purpose

Acne treatment

Uses

  • For the treatment of acne
  • Reduces the number of acne pimples
  • Allows skin to heal
  • Penetrates pores to clear most acne blemishes
  • Dries up acne pimples
  • Helps keep skin clear of new acne blemishes, acne pimples, whiteheads and blackheads

Warnings

For external use only

Otc - When Using

When using this product, skin irritation and dryness may occur if you use other topical acne medications at the same time or immediately following use of this product. If this occurs, use only one medication at a time unless directed by a doctor. Avoid contact with eyes. If product gets in eyes, rinse with water.

Otc - Stop Use

Stop use and ask a doctor if excessive skin irritation occurs

Otc - Keep Out Of Reach Of Children

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

Directions

  • Apply liberally over wet skin with a clean wash cloth or body puff, concentrating on areas prone to acne.
  • Rinse thoroughly and pat dry with a clean towel.
  • If bothersome dryness or peeling occurs, reduce application to every other day.

Other Information

  • Store at room temperature

Inactive Ingredients

Sodium Palmate, Sodium Cocoate and/or Sodium Palm Kernelate, Water, Glycerin, Sodium Laureth Sulfate, Sodium Hydroxide, Titanium Dioxide, Sodium Chloride, Glycereth-26, Tetrasodium EDTA, Sodium Bicarbonate, Glycolic Acid, Prunus Persica Fruit Extract, Mineral Oil, Stearic Acid, Glyceryl Stearate, Cetyl Alcohol, Salix Nigra Bark Extract, Sodium Chloride, Disodium EDTA, Citric Acid, Triethanolamine, Opuntia Vulgaris Extract, Sucrose, Pentasodium Pentetate.

Principal Display Panel - 113 G Bar Carton

FOR ALL SKIN TYPES

Asepxia®
WITH HYDRO-FORCE™

Acne Bar Soap
with BAKING SODA

DEEP PORE CLEANSER

  • >With Salicylic Acid.
  • >Deeply cleanses dirt and oil from pores.
  • >Fights imperfections.

    • Net Wt. 4 oz (113 g)

    Principal Display Panel (113 g Bar Carton)

    Principal Display Panel (113 g Bar Carton)

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