Oxy 5 Lotion
FDA Label NDC 10742-8355

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 5 (NDC 10742-8355). 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, do not use if you, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Benzoyl peroxide 5%

Purpose

Acne treatment

Uses

treats and helps prevent acne

Warnings

For external use only

Do Not Use If You

  • have very sensitive skin
  • are sensitive to benzoyl peroxide

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.
  • avoid unnecessary sun exposure and use a sunscreen
  • avoid contact with the eyes, lips, and mouth
  • avoid contact with hair and dyed fabrics, which may be bleached by this product
  • skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using this product less frequently or in a lower concentration.

Stop Use And Ask A Doctor If

irritation becomes severe

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

  • clean skin thoroughly before applying this product
  • cover entire affected area with a thin layer 1 to 3 times daily
  • 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
  • if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.

Inactive Ingredients

anhydrous citric acid, carbomer homopolymer, diazolidinyl urea, diethylhexyl sodium sulfosuccinate, dimethicone, edetate disodium, glycerin, lauryl methacrylate/glycol dimethacrylate crosspolymer, propylene glycol, purified water, silica, sodium citrate, sodium hydroxide, xanthan gum

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