Label: NEOVA BREAKOUT CONTROL- salicylic acid swab

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 28, 2011

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  • Active Ingredients

    Salicylic Acid 2%

  • Purpose

    Acne Treatment

  • Uses

    • For the treatment of acne. • Helps prevent new acne pimples,
    blackheads and whiteheads.

  • Warnings

    For external use only

  • When using this product

    Avoid contact with eyes. If contact occurs, flush
    thoroughly with water. Using other topical acne medications at the same time
    or immediately following use of this product may increase dryness or
    irritation of the skin. If this occurs, only one medication should be used unless
    directed by a doctor. Do not insert in ear canal.

  • Keep out of reach of children.

    If swallowed, contact a Poison Control
    Center immediately or get medical help right away.

  • Directions

    • Snap the tip at the color ring. • Allow formula to flow down
    to the opposite tip. • Apply formula with the saturated tip to affected area.

  • Other Information

    Avoid storing at excessive heat.

  • Inactive Ingredients

    Allantoin, Hamamelis Virginiana (Witch Hazel)
    Water, Aloe Barbadensis Leaf Extract, Isoceteth-20, Methyl Gluceth-20, PEG-6,
    Propylene Glycol, Sodium Hydroxide, Sodium PCA, Sorbitol, Tetrasodium EDTA,
    Water (Aqua).

  • Image of Box Label

    BreakOutControlBoxLabel112611.jpgImage of Box/Label

  • INGREDIENTS AND APPEARANCE
    NEOVA   BREAKOUT CONTROL
    salicylic acid swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62362-119
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid2 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Allantoin (UNII: 344S277G0Z)  
    Hamamelis Virginiana Leaf Water (UNII: 8FP93ED6H2)  
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Isoceteth-20 (UNII: O020065R7Z)  
    Methyl Gluceth-20 (UNII: J3QD0LD11P)  
    Polyethylene Glycol 300 (UNII: 5655G9Y8AQ)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2)  
    Sorbitol (UNII: 506T60A25R)  
    Edetate Sodium (UNII: MP1J8420LU)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62362-119-3636 in 1 BOX
    1NDC:62362-119-055 mL in 1 APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358B12/27/2011
    Labeler - PhotoMedex, Inc. (054503875)
    Establishment
    NameAddressID/FEIBusiness Operations
    PhotoMedex, Inc.054503875manufacture
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