Spot Acne Treatment 0.75oz Gel
FDA Label NDC 57337-149

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rejoice International Corp. for the product Spot Acne Treatment 0.75oz (NDC 57337-149). 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, use, warnings, when using this product, do not use if you, stop use and ask a doctor if, keep out of reah of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient

→ Purpose

→ Use

→ Warnings

→ When Using This Product

→ Do Not Use If You

→ Stop Use And Ask A Doctor If

→ Keep Out Of Reah Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Label

Active Ingredient

Benzoyl Peroxide 2.5%

Purpose

Acne Medication

Use

For the treatment of acne

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.

avoid unnecessary sun exposure and use sunscreen.
avoid contact with the eyes, lips, and mouth.
avoid contact with hair and dyed fabrics, which may be bleached by this product.
skin irritation may occur, charactherized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.

Do Not Use If You

Do not use if you

have very sensitive skin
are sensitive to benzoyl peroxide

Stop Use And Ask A Doctor If

irritation becomes severs.

Keep Out Of Reah Of Children

If 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 directed by a doctor.
if some dryness or peeling occurs, reduce application to once a day or every other day.
If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.