Oxy 3 In 1 Acne Pads Swab
FDA Label NDC 10742-4359

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by The Mentholatum Company for the product Oxy 3 In 1 Acne Pads (NDC 10742-4359). 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, when using this product, if pregnant or breast-feeding, 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

Active Ingredient

Salicylic acid 2%

Purpose

Salicylic acid - Acne treatment

Uses

treats and helps prevent acne

Warnings

For external use only

When Using This Product

  • keep away from eyes, lips and mouth. If contact occurs, flush thoroughly with water.
  • 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.
  • do not leave pad on skin

If Pregnant Or Breast-Feeding

ask a health professional before use.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • use a pad to cleanse and cover the affected area with a thin layer of medicine 1 to 3 times daily
  • because too much drying of the skin may occur, start with 1 application, then gradually increase to 2 or 3 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
  • Sensitivity test: Apply product sparingly to a small affected area for the first 3 days. If no discomfort occurs, follow directions above.

    • Other information

    • KEEP TIGHTLY CLOSED
    • avoid storing at temperatures above 100˚F (38˚C)
    • protect from freezing
    • keep away from flame, fire and heat

Inactive Ingredients

alcohol (50% v/v), allantoin, capryloyl glycine, fragrance, isoceteth-20, jojoba wax PEG-120 esters, PEG-8/SMDI copolymer, phytic acid, purified water, trisodium EDTA, trolamine

Questions?

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