Active Ingredient
Salicylic Acid 1% w/v
Aftaseptic Liquid
FDA Label NDC 73635-7102
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Germa Products, Llc for the product Aftaseptic (NDC 73635-7102). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, indications & usage, warnings, other information, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
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 15° to 30°C (59° to 86°F). 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.
Package Label.Principal Display Panel
Aftaseptic
Aftaseptic (Aftaseptic)
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