Acne Spot Treatment Cream
FDA Label NDC 61328-404

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Skinfix, Inc. for the product Acne Spot Treatment (NDC 61328-404). 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, otc - keep out of reach of children, directions, inactive ingredients, questions?, 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

ACNE TREATMENT

Uses

HELPS CLEAR ACNE BLEMISHES AND ALLOWS SKIN TO HEAL. HELPS KEEP SKIN CLEAR OF NEW ACNE BLEMISHES. HELPS PREVENT NEW ACNE BLEMISHES FROM FORMING.

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 TIME. IF IRRITATION OCCURS, ONLY USE ONE TOPICAL ACNE MEDICATION AT A TIME.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away

Directions

APPLY DIRECTLY ONYO BLEMISH OR AFFECTED AREA AFTER CLEANSING 1-2X DAILY.

ALLERGY ALERT  DO NOT USE THIS PRODUCT IF YOU HAVE A KNOWN ALLERGY TO SALICYLIC ACID.

Inactive Ingredients

WATER (EAU), KAOLIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, AZELAIC ACID, PROPANEDIOL, STEARYL ALCOHOL, POLYGLYCERYL-2 STEARATE, NIACINAMIDE, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, GLYCERIN, BENTONITE, TOCOPHEROL, POLYDEXTROSE, DEXTRIN, AMYLOPECTIN, GLYCERYL STEARATE, ZINC PCA, STEARYL GLYCYRRHETINATE, ETHYLHEXYLGLYCERIN, XANTHAN GUM, CITRIC ACID, POTASSIUM CETYL PHOSPHATE, PHENOXYETHANOL, SODIUM HYDROXIDE, POTASSIUM SORBATE, SODIUM BENZOATE

Questions?

1.866.927.2783

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