Oxy Lotion
FDA Label NDC 10742-1314

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 10742-1314). 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, keep out of reach of children, uses, warnings, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Benzoyl peroxide 2.5%

Purpose

Benzoyl peroxide – Acne treatment

Keep Out Of Reach Of Children

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

Uses

  • For the treatment of acne.
  • Helps prevent new acne blemishes.

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, use only 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 the 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.

Directions

  • clean the skin thoroughly before applying this product
  • use a dime-sized amount to cover the entire affected area with a thin layer one to two 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 going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.
  • Sensitivity Test for a 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

    • THIS PRODUCT MAY BLEACH HAIR OR DYED FABRICS
    • KEEP TIGHTLY CLOSED
    • avoid storing at temperatures above 100°F (38°C)

Inactive Ingredients

water, glycerin, butylene glycol, carbomer, chlorphenesin, citric acid, dimethyl isosorbide, disodium EDTA, hyaluronic acid, hydrolyzed algin, lauryl methacrylate/glycol dimethacrylate crosspolymer, PEG/PPG-4/12 dimethicone, phenoxyethanol, phytic acid, portulaca oleracea extract, silanetriol, sodium citrate, sodium hydroxide, xanthan gum, zinc sulfate

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