Spot Correction Cream
FDA Label NDC 60934-002

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Hydropeptide Llc for the product Spot Correction (NDC 60934-002). 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 ingredients, purpose, uses, warnings, do not use on:, when applying this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Colloidal Sulfur (3%)

Purpose

Acne treatment ointment

Uses

  • treats acne
  • helps prevent new pimples
  • clears up most acne pimples

Warnings

For external use only

Do Not Use On:

  • broken skin
  • large areas of the body

When Applying This Product

  • apply only to areas with acne
  • rinse right away with water if it gets in eyes
  • 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.

Stop Use And Ask A Doctor If

  • skin irritation occurs or gets worse

Keep Out Of Reach Of Children.

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

Directions

  • clean the skin thoroughly before applying this product
  • cover the entire affected area with a thin layer one to three 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

Other Information

  • store at controlled room temperature (59° - 86°F)

Inactive Ingredients

4-t-Butylcyclohexanol, Acacia Senegal Gum, Arginine, Chondrus Crispus (Carrageenan), Citrus Grandis (Grapefruit) Peel Oil, Epilobium Angustifolium Flower/Leaf/Stem Extract, Lactic Acid, Leuconostoc/Radish Root Ferment Filtrate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Niacinamide, Pentylene Glycol, Rice Ferment (Sake) Filtrate, Sodium Hydroxide, Water (Aqua), Xanthan Gum

Questions Or Comments?

Call 1.800.932.9873

Package Labeling:

Label3 (Label3)

Label3 (Label3)

* Please review the disclaimer below.