Careone
FDA Label NDC 41520-622

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by American Sales Company for the product Careone (NDC 41520-622). 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, uses, warnings, ask a doctor before use if you have, 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

SELENIUM SULFIDE 1%

Purpose

ANTI-DANDRUFF/ANTI-SEBORRHEIC DERMATITIS

Uses

FOR THE RELIEF OF FLAKING AND ITCHING ASSOCIATED WITH DANDRUFF AND SEBORRHEIC DERMATITIS AND TO HELP PREVENT THE CHANCE OF RECURRENCE

Warnings

FOR EXTERNAL USE ONLY

Ask A Doctor Before Use If You Have

SEBORRHEIC DERMATITIS IN AREAS OTHER THAN THE SCALP

When Using This Product

  • AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER
  • FOR USE ON COLOR TREATED OR PERMED HAIR, RINSE THOROUGHLY

Stop Use And Ask A Doctor If

CONDITION WORSENS OR DOES NOT IMPROVE AFTER REGULAR USE OF THIS PRODUCT AS DIRECTED

Keep Out Of Reach Of Children

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY

Directions

  • SHAKE WELL, APPLY SHAMPOO AND RINSE THOROUGHLY
  • FOR BEST RESULTS, USE AT LEAST TWICE A WEEK OR AS DIRECTED BY A DOCTOR

Other Information

STORE AT ROOM TEMPERATURE

Inactive Ingredients

WATER (AQUA), SODIUM LAURETH SULFATE, DISTEARYL PHTHALIC ACID AMIDE, SODIUM CHLORIDE, COCAMDIOPROPYL BETAINE, SODIUM STEAROYL LACTYLATE, DIMETHICONE, DMDM HYDANTOIN, CITRIC ACID, FRAGRANCE (PARFUM), SODIUM HYDROXIDE, SODIUM CITRATE, ALOE BARBADENSIS LEAF JUICE, HYDROXYPROPYL METHYLCELLULOSE, TITANIUM DIOXIDE, BLUE 1 (CI 42090)

Label Copy

Image Of The Label (19813l)

Image Of The Label (19813l)

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