ASEPTIL ROJO- phenol liquid

Aseptil Rojo by

Drug Labeling and Warnings

Aseptil Rojo by is a Otc medication manufactured, distributed, or labeled by Menper Distributors, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

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.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

OTHER SAFETY INFORMATION

Other Information

• Store at room temperature

INACTIVE INGREDIENT

Inactive ingredients

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

WARNINGS

Tamper Evident: DO NOT USE IF PRINTED SAFETY SEAL IS TORN, BROKEN OR MISSING.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ASEPTIL ROJO 
phenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53145-004
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Phenol (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV)	Phenol	1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	red	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53145-004-01	1 in 1 CARTON
1		30 mL in 1 BOTTLE, SPRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/21/2012

Labeler - Menper Distributors, Inc. (101947166)