Label: TAKE CONTROL CALMING CLEANSER- salicylic acid gel

  • NDC Code(s): 49520-104-11, 49520-104-15, 49520-104-31, 49520-104-33, view more
    49520-104-35, 49520-104-51
  • Packager: mybody
  • 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 12/13

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

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT

    SALICYLIC ACID 2%

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  • PURPOSE

    PURPOSE

    ACNE TREATMENT

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  • INDICATIONS & USAGE

    USE FOR TREATMENT OF ACNE

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  • WARNINGS

    WARNINGS

    FOR EXTERNAL USE ONLY

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  • DO NOT USE

    DO NOT USE * IF YOU HAVE VERY SENSITIVE SKIN OR ARE SENSITIVE TO SALICYLIC ACID.

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  • ASK DOCTOR/PHARMACIST

    ASK A DOCTOR OR PHARMACIST BEFORE USE IF *PREGNANT OR LACTATING. 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.

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  • WHEN USING

    WHEN USING THIS PRODUCT * AVOID CONTACT WITH EYES. IF CONTACT OCCURS, FLUSH THOROUGHLY WITH WATER. * KEEP AWAY FROM LIPS AND MOUTH.

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  • KEEP OUT OF REACH OF CHILDREN

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

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  • DOSAGE & ADMINISTRATION

    DIRECTIONS

    * USE AM/PM OR AS DIRECTED BY A DOCTOR. APPLY A NICKEL-SIZE AMOUNT TO WET HANDS. RUB TOGETHER. GENTLY MASSAGE ONTO FACE AND NECK WITH CIRCULAR MOTIONS. LEAVE ON 1-2 MINUTES THEN RINSE WELL.

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  • OTHER SAFETY INFORMATION

    OTHER INFORMATION

    * AVOID STORAGE AT EXTREME TEMPERATURES (BELOW 40°F AND ABOVE 100°F).

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  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS: WATER, DISODIUM LAURETH SULFOSUCCINATE, SODIUM COCOYL ISETHIONATE, SODIUM LAUROAMPHOACETATE, GLYCERIN, SODIUM METHYL COCOYL TAURATE, METHYLISOTHIAZOLINONE, COCAMIDOPROPYL BETAINE, BISABOLOL, ZINGIBER OFFICINALE (GINGER) ROOT EXTRACT, OAT (AVENA SATIVA) KERNEL EXTRACT, DISODIUM EDTA, BETA GLUCAN, EUCALYPTUS GLOBULUS OIL, XANTHAN GUM, MENTHOL, MYRISTOYL TETRAPEPTIDE-13, ACETYL CARBOXYMETHYL COCOYL GLYCINE, PHENOXYETHANOL, CAPRYLYL GLYCOL.

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  • QUESTIONS

    QUESTIONS OR COMMENTS?

    CALL 877.423.1314 * WWW.LOVEMYBODY.COM

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  • INGREDIENTS AND APPEARANCE
    TAKE CONTROL CALMING  CLEANSER
    salicylic acid gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:49520-104
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 2 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    DISODIUM LAURETH SULFOSUCCINATE  
    SODIUM COCOYL ISETHIONATE  
    SODIUM LAUROAMPHOACETATE  
    GLYCERIN  
    SODIUM METHYL COCOYL TAURATE  
    METHYLISOTHIAZOLINONE  
    COCAMIDOPROPYL BETAINE  
    .ALPHA.-BISABOLOL, (+/-)-  
    GINGER  
    OAT  
    EDETATE DISODIUM  
    CURDLAN  
    EUCALYPTUS OIL  
    XANTHAN GUM  
    MENTHOL  
    MYRISTOYL PENTAPEPTIDE-4  
    ACETYL CARBOXYMETHYL COCOYL GLYCINE  
    PHENOXYETHANOL  
    CAPRYLYL GLYCOL  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49520-104-31 5 mL in 1 TUBE
    2 NDC:49520-104-15 150 mL in 1 BOTTLE
    3 NDC:49520-104-51 1 in 1 BOX
    3 NDC:49520-104-11 150 mL in 1 BOTTLE
    4 NDC:49520-104-33 10 mL in 1 TUBE
    5 NDC:49520-104-35 150 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333D 09/27/2012
    Labeler - mybody (004460532)
    Establishment
    Name Address ID/FEI Business Operations
    OWEN BIOSCIENCES INC 790003045 manufacture(49520-104)
    Establishment
    Name Address ID/FEI Business Operations
    COSMETIC ENTERPRISES LTD 017701475 repack(49520-104)
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