Oc Eight
FDA Label NDC 42485-003

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Biopelle, Inc. for the product Oc Eight (NDC 42485-003). 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, do not use if you, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Benzoyl peroxide 7%

Purpose

Acne Treatment

Use

for the treatment of acne

Warnings

For external use only.

Do Not Use If You

  • have very sensitive skin
  • are sensitive to benzoyl peroxide

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, use only one topical acne medication at a time.
  • avoid unnecessary sun exposure and use a 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, characterized by redness, burning, itching, peeling, or possible swelling.  Irritation may be reduced by using the product less frequently or in a lower concentration.

Stop Use And Ask A Doctor If

  • irritation becomes severe

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • cleanse the skin thoroughly before applying
  • cover the entire affected area with a thin layer 1 to 3 times a day
  • because excessive drying of th 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
  • if going outside, apply a sunscreen after using this product.  Allow OC Eight Acne Mattifying Gel to dry, then follow directions in the sunscreen labeling.  If irritation or sensitivity develops, stop use of both products and ask a doctor.

Other Information

Store at controlled room temperature 59° - 86° F (15° - 30° C).

Inactive Ingredients

water, DVB/isobornyl methacrylate/lauryl methacrylate copolymer, propylene glycol, PEG-400, carbomer 940, sodium hydroxide, disodium EDTA

Questions?

1-866-424-6735 weekdays

Package Label

LET ME BE PERFECTLY CLEAR Acne Treatment Kit NDC 42485-004-01

AFA Cream Cleanser with Dead Sea Minerals 8 fl oz / 236 mL

PRESCRIBEDsolutions Line Subtractor 27 mL / .9 fl oz

OC Eight® Acne Mattifying Gel 1.6 oz / 45 g

Marketed by Biopelle, Inc.
A Ferndale Pharma Group company
Ferndale, Michigan 48220
www.biopelle.com

Letmebeperfectlyclearcartonfront (Letmebeperfectlyclearcartonfront)

Letmebeperfectlyclearcartonfront (Letmebeperfectlyclearcartonfront)


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