Label: CARE ONE MOISTURIZING- selenium sulfide liquid

  • NDC Code(s): 41520-621-11
  • Packager: AMERICAN SALES COMPANY
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 07/13

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    SELENIUM SULFIDE 1%

    PURPOSE

    ANTIDANDRUFF

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  • USE

    CONTROLS FLAKING, SCALING AND ITCHING ASSOCIATED WITH DANDRUFF.

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  • WARNINGS

    FOR EXTERNAL USE ONLY.

    DO NOT USE

    ON SCALP THAT IS BROKEN OR INFLAMED, IF YOU ARE ALLERGIC TO INGREDIENTS IN THIS PRODUCT.

    WHEN USING THIS PRODUCT

    AVOID CONTACT WITH EYES. IF PRODUCT GETS INTO EYES, RINSE EYES THOROUGHLY WITH WATER.

    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

    IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

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  • DIRECTIONS

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

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  • OTHER INFORMATION

    STORE AT ROOM TEMPERATURE.

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  • INACTIVE INGREDIENTS:

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

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  • QUESTIONS/COMMENTS?

    1-866-695-3030

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  • LABEL COPY
  • INGREDIENTS AND APPEARANCE
    CARE ONE  MOISTURIZING
    selenium sulfide liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:41520-621
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SELENIUM SULFIDE (SELENIUM SULFIDE) SELENIUM SULFIDE 10 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    SODIUM LAURETH SULFATE  
    DISTEARYL PHTHALAMIC ACID  
    SODIUM CHLORIDE  
    COCAMIDOPROPYL BETAINE  
    SODIUM STEAROYL LACTYLATE  
    DIMETHICONE  
    DMDM HYDANTOIN  
    CITRIC ACID MONOHYDRATE  
    SODIUM CITRATE  
    ALOE VERA LEAF  
    HYPROMELLOSES  
    TITANIUM DIOXIDE  
    FD&C BLUE NO. 1  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41520-621-11 325 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part358H 07/15/2013
    Labeler - AMERICAN SALES COMPANY (809183973)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    Name Address ID/FEI Business Operations
    APOLLO HEALTH AND BEAUTY CARE 201901209 manufacture(41520-621)
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