Label: INIXIAL PERFECTION STOP BLEMISHES SALICYLIC ACID 2% ACNE TREATMENT- salicylic acid cream

  • 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 April 4, 2016

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  • Drug Facts

  • Active ingredients

    Salicylic acid 2%

    Purpose

    Acne treatment solution

  • Uses

    • For the treatment of acne.
    • Dries and clears acne blemishes and allows skin to heal.
  • Warnings

    For external use only   

    When using this product

    • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time

    Keep out of reach of children.

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

  • Directions

    • Clean the skin thoroughly before applying this product.
    • Cover the entire affected area with a thin layer one to three times daily.
    • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.
    • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

    Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above.

  • Inactive ingredients

    water (aqua), SD alcohol 40-B, propanediol, citric acid, bamboo (Bambusa arundinacea) stem extract, cellulose, sodium hydroxide, polycrylate crosspolymer-6, alcohol, xanthan gum, glycerin, orris (Iris florentina) root extract, hydrogenated coconut acid, retinyl palmitate, zinc sulfate, sodium phytate, t-butyl alcohol, heather (Calluna vulgaris) flower extract, coco-caprylate/caprate, palmitoyl pine bark extract, palmitic acid.

  • Questions?

    Call toll-free 1-800-322-3507

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    INIXIAL PERFECTION STOP BLEMISHES SALICYLIC ACID 2% ACNE TREATMENT 
    salicylic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70532-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    PALMITIC ACID (UNII: 2V16EO95H1)  
    WATER (UNII: 059QF0KO0R)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ALCOHOL (UNII: 3K9958V90M)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    IRIS PALLIDA ROOT (UNII: LVV57EM5OG)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    ZINC SULFATE (UNII: 89DS0H96TB)  
    PHYTATE SODIUM (UNII: 88496G1ERL)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    CALLUNA VULGARIS FLOWERING TOP (UNII: D9PC510CQV)  
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70532-004-011 in 1 CARTON04/03/2016
    110 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D04/01/2016
    Labeler - IXXI S.A.S (263290505)
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