Oxy
FDA Label NDC 10742-1101

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 (NDC 10742-1101). 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 0.5%

Purpose

Salicylic acid - Acne treatment

Uses

  • for the treatment of acne
  • clears acne pimples and allows skin to heal
  • penetrates pores to control blackheads and whiteheads
  • helps prevent new acne pimples from forming

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.

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

  • cleanse skin thoroughly before applying this product
  • apply patch(es) to affected area(s)
  • to remove, gently peel back patch and discard
  • because excessive drying of the skin may occur, start with 1 application daily, 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

Storage And Handling

  • do not store above 25OC (77OF)

Inactive Ingredients

acrylates/ethylhexyl acrylate copolymer, water, nonoxynol-30, alcohol denatured, butylene glycol, C13-14 isoparaffin, epilobium angustifolium flower/leaf/stem extract, kaolin, laureth-7, melaleuca alternifolia (tea tree) leaf oil, phenoxyethanol, phytosphingosine, polysorbate 80, PVP, sodium hyaluronate, sodium hydroxide, sodium metabisulfite, sodium polyacrylate, vitis vinifera (grape) seed extract, volcanic ash

Questions?

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