Mineral Blemish Kit
FDA Label NDC 76354-205

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by J. A. Cosmetics U.s. Inc for the product Mineral Blemish Kit (NDC 76354-205). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - ask doctor, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

Active Ingredient:

SULFUR (3%)

Otc - Purpose

Purpose:

ACNE TREATMENT

Indications & Usage

Uses:

  • FOR TREATMENT OF ACNE
  • HELPS KEEP SKIN CLEAR OF NEW ACNE BLEMISHES AND ALLOWS SKIN TO HEAL

Warnings

Warning:

For external use only

Otc - When Using

When Using This Product

  • USING OTHER TROPICAL ACNE MEDICATIONS AT THE SAME TIME OR IMMEDIATELY FOLLOWING USE OF THIS PRODUCT MAY INCREASE DRYNESS OR IRRITATION OF SKIN. IF OCCURS, ONLY ONE MEDICATION SHOULD BE USED UNLESS DIRECTED BY A DOCTOR.

Otc - Ask Doctor

Stop use and ask a doctor if

  • rash occurs.

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN.

Dosage & Administration

Directions:

  • TAKE THE CONCEALER BRUSH AND DAB INTO THE POWDER. APPLY FORMULA ON AREAS THAT NEED SPOT TREATMENT. USE NIGHTLY TO TREAT AND PREVENT FUTURE BREAKOUTS. AVOID WOUNDS OR ON AREAS OF ECZEMA.

Inactive Ingredient

Inactive Ingredient:

MICA, BISMUTH OXYCHLORIDE, ALUMINUM STARCH OCTENYLSUCCINATE, PARAFFINIUM LIQUIDUM (MINERAL OIL), MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL, SODIUM DEHYDROACETATE. MAY CONTAIN: IRON OXIDES (CI 77491, CI 77492, CI 77499)

* Please review the disclaimer below.