Salicylic Acid Gel
FDA Label NDC 81993-020

12 label sections · Submitted to the FDA by Zennova Llc · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Zennova Llc for the product Salicylic Acid (NDC 81993-020). 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 active ingredient, purpose, uses, warnings, otc - pregnancy or breast feeding, when using this product, keep out of the reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Salicylic Acid 2%

Purpose

Acne treatment

Uses

For the treatment of acne.

  • Clears acne blemishes (blackheads, whiteheads, pimples) and allows skin to heal.
  • Helps prevent new acne blemishes from forming.

Warnings

For external use only.

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.
  • Keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Keep Out Of The Reach Of Children.

  • If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) 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 to 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.

Other Information

  • Sealed and stored at room temperature
  • Close cap tightly after use
    TAMPER EVIDENT: DO NOT USE IF SEAL ON TUBE IS BROKEN OR MISSING.

Inactive Ingredients

Citric acid, Disodium edetate, Hydroxyethyl cellulose, Phenoxyethanol, Propylene glycol, Purified water, Triethanolamine

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