Caraderma
FDA Label NDC 51130-333

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by A Refreshing Discovery, Inc. for the product Caraderma (NDC 51130-333). 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, keep out of reach of children.  if swallowed, get medical help or contact a poison control center immediately., inactive ingredients, directions, package/label principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Benzoyl Peroxide 7.5%

Purpose

Acne Treatment

Use

for the management of acne

Warnings

For external use only

Do not use this medication if you have very sensitive skin or if you are sensitive to benzoyl peroxide.

Ask a doctor 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.

When using this product

  • Do not use in or near eyes. If contact occurs, rinse thoroughly with water.
  • Keep away from lips and mouth.
  • Avoid unnecessary sun exposure and use a sunscreen.

    • Stop use and ask a doctor if skin irritation occurs.

Keep Out Of Reach Of Children.  If Swallowed, Get Medical Help Or Contact A Poison Control Center Immediately.

Other information

This product may bleach hair or dyed fabrics. Store at 20-25°C (68-77°F).

Inactive Ingredients

Aluminum Hydroxide, Bentonite, Carbomer Homopolymer Type C, Cetyl Alcohol, Diazolidinyl Urea, Glyceryl Monostearate, Hepes, Hydrocortisone, Isopropyl Myristate, Methylparaben, Phenacetin, Polyethylene Glycol, Propylene Glycol, Propylparaben, Sodium Benzoate, Water

Directions

  • Cleanse the skin thoroughly before applying.
  • Cover the entire affected area with a thin layer one to three times daily.
  • Because excessive drying may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.
  • If going outside, use a sunscreen.
  • Allow CaraDerma® to dry before applying sunscreen.
  • If irritation or sensitivity develops, discontinue use and consult a doctor.

Package/Label Principal Display Panel

CaraDerma®

OOO acne treatment

anti-inflammatory properties

works on cystic acne

fast acting

For Moderate to Severe Acne

Works on All Skin Types

Active Ingredient:

Benzoyl Peroxide 7.5%

Net Wt: 1/2 oz. (15 grams)

Manufactured for

A Refreshing Discovery, Inc.

Raleigh, NC 27614

Made in the USA

Caraderma Carton Label (98f9f508 2419 4c45 Aee4 4c0974423010 01)

Caraderma Carton Label (98f9f508 2419 4c45 Aee4 4c0974423010 01)

Carton Label

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