ASEPTIL ROJO- phenol spray 
Menper Distributors, Inc.

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.

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Active Ingredient

Phenol 1.4%

Purpose

Oral Analgesic/Anesthetic

Uses

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

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

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

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. 

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 ingredients

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

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

image description

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)

Revised: 4/2021
 
Menper Distributors, Inc.