Intensive Face And Body Acne Treatment
FDA Label NDC 58876-107

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dr Lin Skincare for the product Intensive Face And Body Acne Treatment (NDC 58876-107). 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 - do not use, otc - ask doctor/pharmacist, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

ACTIVE INGREDIENT

BENZYL PEROXIDE 10%

Otc - Purpose

PURPOSE

ACNE TREATMENT

Indications & Usage

USE

FOR THE TREATMENT OF ACNE AND ACNE DARK AND RED MARKS.

Warnings

WARNINGS

FOR EXTERNAL USE ONLY

Otc - Do Not Use

DO NOT USE THIS MEDICATION IF YOU

  • HAVE VERY SENSITIVE SKIN OR IF YOU ARE SENSITIVE TO BENZOYL PEROXIDE.

Otc - Ask Doctor/Pharmacist

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

Otc - When Using

When using this product

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

Otc - Stop Use

STOP USE AND ASK A DOCTOR IF IRRITATION BECOMES SEVERE.

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN. IF PRODUCT IS SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

Dosage & Administration

Directions

  • wet area to be cleansed.
  • apply small amount to skin.
  • gently massage to create lather.
  • rinse thoroughly and pat dry.
  • because excessive drying of the skin may occur, start with one application daily, then gradually increase to twice daily if needed or directed by a doctor.
  • if bothersome dryness or peeling occurs, reduce application to once a day or every other day. If going outside, apply sunscreen after using this product.

Other Safety Information

Other information

  • sensitivity test for new users: apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated.
  • avoid contact with hair and dyed fabrics, which may be bleached by this product.

Inactive Ingredient

INACTIVE INGREDIENTS

Water, Sodium C14-16 Olefin Sulfonate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Glycerin, Aloe Barabadensis Leaf Extract, Sodium PCA, Allantoin, Panthenol, Phenoxyethanol, Methylisothiazolinone, Citrus Arantium Bergamia (Bergamot) Fruit Extract, Sodium Hydroxide

Otc - Questions

QUESTIONS OR COMMENTS?

1-877-445-4624

MON-FRI 8AM - 5PM (PST)

Package Label.Principal Display Panel

Dlsc_6ozintensivefacebody_proofr1 (Dlsc 6ozintensivefacebody Proofr1)

Dlsc_6ozintensivefacebody_proofr1 (Dlsc 6ozintensivefacebody Proofr1)

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