Puraclear Advanced Skincare Acne Moisturizer Lotion
FDA Label NDC 88016-017

13 label sections · Submitted to the FDA by Puraclear Llc · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Puraclear Llc for the product Puraclear Advanced Skincare Acne Moisturizer (NDC 88016-017). 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 drug facts, active ingredient, purpose, uses, warnings, when using 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

Drug Facts

Active Ingredient

Salicylic Acid 0.5%

Purpose

Acne treatment

Uses

  • For the treatment of acne.
  • Penetrates pores to clear most acne blemishes.
  • Helps keep skin clear of new acne pimples, blackheads, or whiteheads.

Warnings

For external use only

When Using This Product

  • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same or immediately following use of this product. If this occurs, use only one topical acne medication at a time.

Stop Use And Ask A Doctor If

  • irritation becomes severe.

Keep Out Of Reach Of Children.

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

If Pregnant Or Breast-Feeding,

ask a health professional before use.

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

  • Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

Water (Aqua), Ethoxydiglycol, Dicaprylyl Ether, Glycerin, Neopentyl Glycol Diheptanoate, Cetearyl Alcohol, Methyl Gluceth-20, Aluminum Starch Octenylsuccinate, Dimethicone, Microcrystalline Cellulose, Steareth-20, Steareth-2, Ceteth-10 Phosphate, Dicetyl Phosphate, Lecithin, Cellulose Gum, Disodium EDTA, Menthyl Lactate, Xanthan Gum, Phenoxyethanol, Ethylhexylglycerin, Sodium Hydroxide

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