AFTASEPTIC INSTANT PAIN RELIEF- salisylic acid 1% liquid

Aftaseptic by

Drug Labeling and Warnings

Aftaseptic by is a Otc medication manufactured, distributed, or labeled by Germa Products, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Salicylic Acid 1% w/v

Purpose

Analgesic

Uses

For the temporary relief of pain associated with canker sores.

INDICATIONS & USAGE

for the temporary relief of pain associated with canker sores.

Warnings

Alcohol warning: if you consume 3 or more alcoholic drinks everyday, consult with a specialist whether you should use Salicylic Acid or other pain reliever, fever reducers n Salicylic Acid may cause stomach bleeding.

Allergy alert: may cause a severe allergic reaction which may include: hives, facial swelling, asthma (wheezing), shock.

Warnings

Flammable n Keep away from fire or flame. Do not use for teething or in children under 2 years of age
When using this product n avoid contact with eyes. Do not use longer than 1 week unless directed by a doctor. If pregnant or nursing contact a Doctor before using. Stop use and ask a doctor if condition persists or worsen
keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Other Information

Store between 15º to 30ºC (59º to 86ºF). Cap bottle tightly. Do not accept if safety seal is broken or missing. Cap bottle tightly. Keep this box for future doubts.

Directions

Use enclosed applicator brush

Children 14 years of age to adult. Apply 2 brushstrokes 2 times a day to affected area of the mouth, gums or mucous membranes (throat). Do not rinse mouth after use. Children under 14 years of age consult a physician.

Inactive Ingredients

Ethyl Alcohol, propylene glycol, purified water, rhubarb.

PRINCIPAL DISPLAY PANEL

Aftaseptic

INGREDIENTS AND APPEARANCE

AFTASEPTIC  INSTANT PAIN RELIEF
salisylic acid 1% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73635-7102
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALCOHOL (UNII: 3K9958V90M)
RHUBARB (UNII: G280W4MW6E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73635-7102-5	1 in 1 BOX	03/29/2019
1		14.8 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M022	03/29/2019

Labeler - Germa Products, LLC (116626935)