NDC 73635-7102 Aftaseptic Instant Pain Relief

Salisylic Acid 1%

NDC Product Code 73635-7102

NDC 73635-7102-5

Package Description: 1 BOTTLE, WITH APPLICATOR in 1 BOX > 14.8 mL in 1 BOTTLE, WITH APPLICATOR

NDC Product Information

Aftaseptic Instant Pain Relief with NDC 73635-7102 is a a human over the counter drug product labeled by Germa Products, Llc. The generic name of Aftaseptic Instant Pain Relief is salisylic acid 1%. The product's dosage form is liquid and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1047362.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Aftaseptic Instant Pain Relief Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • ALCOHOL (UNII: 3K9958V90M)
  • RHUBARB (UNII: G280W4MW6E)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Germa Products, Llc
Labeler Code: 73635
FDA Application Number: part333D What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 03-29-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Aftaseptic Instant Pain Relief Product Label Images

Aftaseptic Instant Pain Relief Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

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.

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 brushChildren 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.

* Please review the disclaimer below.