Label: REJUVADERM MEDISPA ACNE BACK- salicylic acid spray

  • 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 July 20, 2010

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  • ACTIVE INGREDIENT



    Active Ingredients                  Purpose

    Salicylic acid 2.0%                  Acne Treatment

  • INDICATIONS & USAGE



    Use For the treatment of acne.

    • penetrates pores to control acne blemishes.
    • helps keep skin clear of new acne blemishes.
  • WARNINGS



    Warnings

    For external use only

    When using this product

    • with other topical acne medication at the same time or immediately following the 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. avoid contact with eyes. If eye contact occurs, rinse thoroughly with water. apply to affected area only. do not use on broken skin. do not aply to large areas of the body. Spray in a well ventilated area. Do not inhale.
    • flammable-keep away from open fire or flame.

      Stop use and ask a doctor if
    • rash or irritation develops and lasts.
    Sunburn Alert: this product may increase your skin's sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing and limit sun exposure while using this product and for one week afterwards.
  • DOSAGE & ADMINISTRATION



    Directions

    • Apply byspraying directly onto back.
    • Pump works upside down to secure application.
    • Let dry prior to dressing.
    • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
  • INACTIVE INGREDIENT



    Inactive Ingredients Benzalkonium Chloride, Isopropyl Alcohol, Polysorbate 20, Water (Aqua).

  • PURPOSE



    Acne treatment

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

  • PRINCIPAL DISPLAY PANEL

    label


    Rejuvaderm Medispa

    reawaken the essence that is you

    acne back spray

    8 fl oz. (240 ml)

    401944skin

    www.riskindoc.com

    www.rejuvadermmedispa.com

  • INGREDIENTS AND APPEARANCE
    REJUVADERM MEDISPA ACNE BACK  
    salicylic acid spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51325-400
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID4.8 mL  in 240 mL
    Inactive Ingredients
    Ingredient NameStrength
    Benzalkonium chloride (UNII: F5UM2KM3W7)  
    Isopropyl alcohol (UNII: ND2M416302)  
    Polysorbate 20 (UNII: 7T1F30V5YH)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51325-400-041 in 1 BOX
    1240 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D07/20/2010
    Labeler - Ellen Frankle MD Inc. (603208240)
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