Label: TAKE CONTROL CALMING CLEANSER- salicylic acid gel

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 December 30, 2013

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT

    SALICYLIC ACID 2%

  • PURPOSE

    PURPOSE

    ACNE TREATMENT

  • INDICATIONS & USAGE

    USE FOR TREATMENT OF ACNE

  • WARNINGS

    WARNINGS

    FOR EXTERNAL USE ONLY

  • DO NOT USE

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

  • 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.

  • WHEN USING

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

  • 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.

  • 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.

  • OTHER SAFETY INFORMATION

    OTHER INFORMATION

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

  • 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.

  • QUESTIONS

    QUESTIONS OR COMMENTS?

    CALL 877.423.1314 * WWW.LOVEMYBODY.COM

  • PRINCIPAL DISPLAY PANEL

    5-8 x 2_5ml Die-Line_TAKE CONTROL_V3_1.6.12Take Control ART_Drug Facts Box

  • INGREDIENTS AND APPEARANCE
    TAKE CONTROL CALMING  CLEANSER
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49520-104
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)  
    SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
    SODIUM LAUROAMPHOACETATE (UNII: SLK428451L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    .ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)  
    GINGER (UNII: C5529G5JPQ)  
    OAT (UNII: Z6J799EAJK)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    CURDLAN (UNII: 6930DL209R)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    MENTHOL (UNII: L7T10EIP3A)  
    MYRISTOYL PENTAPEPTIDE-4 (UNII: PMA59A699X)  
    ACETYL CARBOXYMETHYL COCOYL GLYCINE (UNII: 3TNX4P92J3)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49520-104-315 mL in 1 TUBE
    2NDC:49520-104-15150 mL in 1 BOTTLE
    3NDC:49520-104-511 in 1 BOX
    3NDC:49520-104-11150 mL in 1 BOTTLE
    4NDC:49520-104-3310 mL in 1 TUBE
    5NDC:49520-104-35150 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D09/27/2012
    Labeler - mybody (004460532)
    Establishment
    NameAddressID/FEIBusiness Operations
    OWEN BIOSCIENCES INC790003045manufacture(49520-104)
    Establishment
    NameAddressID/FEIBusiness Operations
    COSMETIC ENTERPRISES LTD017701475repack(49520-104)
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