Oxy Cream
FDA Label NDC 10742-1316

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 10742-1316). 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

Salicylic acid 2%

Purpose

Salicylic acid – 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.

When using this product

  • keep away from eyes. 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, use only one topical acne medication at a time.

    • If pregnant or breast-feeding, ask a health professional before use.

Directions

  • wet face
  • dispense one to two pumps into your palm
  • gently massage cleanser onto skin, avoiding eye area
  • rinse thoroughly
  • use one to two times daily
  • 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.

Inactive Ingredients

water, sodium C14-16 olefin sulfonate, disodium cocoamphodiacetate, methyl gluceth-20, sodium cocoyl isethionate, disodium EDTA, fragrance, hydroxypropyltrimonium hyaluronate, PEG-7 glyceryl cocoate, PEG-8 dimethicone, potassium sorbate, sodium benzoate, triethanolamone

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