Acne Tinted Spot Treatment
FDA Label NDC 84262-028

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Glytone, Llc for the product Acne Tinted Spot Treatment (NDC 84262-028). 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 indications & usage, warnings and precautions, dosage & administration, inactive ingredient, otc - active ingredient, warnings, other safety information, recent major changes, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Indications & Usage

→ Warnings And Precautions

→ Dosage & Administration

→ Inactive Ingredient

→ Otc - Active Ingredient

→ Warnings

→ Other Safety Information

→ Recent Major Changes

→ Otc - Keep Out Of Reach Of Children

→ Otc - Purpose

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Indications & Usage

For the treatment of acne.
Dries and helps clear up acne pimples and blackheads.
Helps prevent new acne blemishes from forming

Warnings And Precautions

For external use only

Do not use
• on broken skin
• on large areas of the body

When using this product
• avoid contact with eyes. If contact occurs, rinse thoroughly with water
• apply only to areas with acne
• skin irritation and dryness are 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

Stop use and ask a doctor if
• skin irritation becomes severe

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

Dosage & Administration

Clean the skin thoroughly before applying this product
Cover the entire affected area with a thin layer 1 to 3 times daily
Because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 3 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

• Clean the skin thoroughly before applying this product
• Cover the entire affected area with a thin layer 1 to 3 times daily
• Because excessive drying may occur, start with 1 application daily, then gradually increase to 2 or 3 times daily if needed
• If bothersome dryness or peeling occurs, reduce application to once a day or every other day

Inactive Ingredient

Water, Cyclopentasiloxane, Isocetyl Stearate, Polysorbate 60, Sorbitan Stearate, Steareth-2, PEG-100 Stearate, Steareth-21, Glycerin, Glyceryl Stearate, Butylene Glycol, Cetearyl Alcohol, Bentonite, Dimethicone Crosspolymer, Diazolidinyl Urea, Sodium Hydroxide, Methylparaben, Propylparaben, Fragrance (Parfum), Iron Oxides (CI 77491, CI 77492, CI 77499), Titanium Dioxide (CI 77891)