Aftaseptic Analgesic Liquid

Aftaseptic Analgesic Liquid
SPL v9
SPL
SPL Set ID beb32fba-503a-f5e5-e053-2a95a90a57e5
Route
TOPICAL
Published
Effective Date 2021-03-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (10 mg)
Inactive Ingredients
Propylene Glycol Alcohol Rhubarb

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-03-29

Description

Salicylic Acid 1% w/v

Purpose

Analgesic


Medication Information

Indications and Usage

for the temporary relief of pain associated with canker sores.

Purpose

Analgesic

Description

Salicylic Acid 1% w/v

Uses

For the temporary relief of pain associated with canker sores.

Section 51945-4

Aftaseptic

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.

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.

Active Ingredient

Salicylic Acid 1% w/v

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.

Inactive Ingredients

Ethyl Alcohol, propylene glycol, purified water, rhubarb.


Structured Label Content

Uses

For the temporary relief of pain associated with canker sores.

Indications and Usage (34067-9)

for the temporary relief of pain associated with canker sores.

Section 51945-4 (51945-4)

Aftaseptic

Purpose

Analgesic

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.

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.

Active Ingredient

Salicylic Acid 1% w/v

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.

Inactive Ingredients

Ethyl Alcohol, propylene glycol, purified water, rhubarb.


Advanced Ingredient Data


Raw Label Data

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