Label: ASEPTIL ROJO- phenol spray

  • NDC Code(s): 53145-004-01
  • Packager: Menper Distributors, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 15, 2021

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

  • ACTIVE INGREDIENT

    Active Ingredient

    Phenol 1.4%

  • PURPOSE

    Purpose

    Oral Analgesic/Anesthetic

  • INDICATIONS & USAGE

    Uses

    • for temporary relief of occasional minor irritation, pain, sore mouth, sore throat and pain associated with canker sores.
  • WARNINGS

    Warnings

    Sore throat warning: Sever or persistent sore throat or sore throat accompanied by high fever, headache, nausea and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by a doctor. 

    When using this product do not use more thani directed

    Stop use and ask a doctor if

    • sore mouth symptoms do not improve in 7 days
    • irritation, pain or redness persists or worsens
    • swelling, rash or fever develops
    • difficulty in breathing occurse

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast feeding, ask a health professional befre use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all drugs out of reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center right away. 

  • DOSAGE & ADMINISTRATION

    Directions

    • Apply to the affected area (five sprays)
    • Allow to remain in place for at least 15 seconds, then spit out.
    • Use every 2 hours or as directed by a doctor or dentist.
    • Children under 12 years of age should be supervised in the use of the product.
    • Children under 3 years of age: Consult a dentist or doctor.
  • INACTIVE INGREDIENT

    Inactive ingredients

    • citric acid, FD&C red #40, flavor, glycerin, propylene glycol, sodium citrate,  saccharin sodium, water.
  • QUESTIONS

    Questions? call 1-800-560-5223 M-F 9 AM to 4 PM Eastern

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    ASEPTIL ROJO 
    phenol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53145-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Phenol (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) Phenol1.4 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53145-004-011 in 1 CARTON02/21/2012
    130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35602/21/2012
    Labeler - Menper Distributors, Inc. (101947166)