Asepxia Acne Treatment Cream
FDA Label NDC 50066-064

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 Acne Treatment (NDC 50066-064). 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, when using this product, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

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

Active Ingredient

Salicilic Acid 2%

Purpose

Acne Treatment

Uses

  • for the treatment of acne
  • dries and clears acne blemishes
  • penetrates pores to eliminate most acne blemishes
  • helps prevent new acne blemishes

Warnings

For external use only

When Using This Product

  • skin irritation and dryness is more likely to occur if you use another acne medication at the same time. If irritation occurs, use only one topical acne med cation at a time

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

  • 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 one 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 irritation or sensitivity develops, stop use and ask a doctor

    • Sensitivity test for new user

    • apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above

Other Information

  • Keep tightly closed
  • Store at room temperature

Inactive Ingredients

Acrylamide Sodium Acrylate Copolymer, Cyclopentasiloxane, Ethylhexylglycerin, Glycerin, Paraffinum Liquid, Phenoxyethanol, Polysorbate 20, Propylene glycol, Sodium Citrate, Trideceth-6, Water.

Questions Or Comments?

1 877 994 3666. Monday to Friday, 8am to 6pm, Central time.

Principal Display Panel - 28 G Tube Carton

Asepxia®

ACNE TREATMENT CREAM

2 % SALICYLIC ACID

ELIMINATES MOST PIMPLES AND BLACKHEADS

NET WT.
1 OZ (28 g)

Principal Display Panel (28 g Tube Carton)

Principal Display Panel (28 g Tube Carton)

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