Asepxia Charcoal Acne Bar Soap
FDA Label NDC 50066-801

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 Charcoal Acne Bar (NDC 50066-801). 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

→ Other

→ Active Ingredient

→ Purpose

→ Uses

→ Warnings

→ Otc - When Using

→ Otc - Stop Use

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Otc - Questions

→ Principal Display Panel - 113 G Bar Carton

Other

Drug Facts

Distributed by: Genomma Lab USA Inc., Houston, TX 77027

Active Ingredient

Salicylic Acid, 2%

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, Activated Charcoal, Sodium Chloride, Iron Oxide (CI 77499), Pentasodium Pentetate