UltraSal-ER

Name: UltraSal-ER

UltraSal-ER Side Effects

Salicylic acid topical can cause a rare but serious allergic reaction or severe skin irritation. These reactions may occur just a few minutes after you apply the medicine, or within a day or longer afterward.

Stop using this medicine and get emergency medical help if you have signs of an allergic reaction: hives, itching; difficult breathing, feeling light-headed; swelling of your face, lips, tongue, or throat.

Stop using salicylic acid topical and call your doctor at once if you have:

  • severe headache, ringing in your ears, problems with hearing, thinking problems;
  • severe stomach pain, vomiting, or diarrhea;
  • a light-headed feeling, like you might pass out;
  • shortness of breath; or
  • severe burning, dryness, or irritation of the skin.

Common side effects may include:

  • minor skin irritation, rash, or peeling; or
  • changes in the color of treated skin (usually whitening).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

UltraSal-ER Interactions

Wart remover medicine may be flammable. Do not use near high heat or open flame such as a burning candle. Wash the medicine off your hands before handling a hair styling appliance (such as a curling or straightening iron). High heat could cause the medicine to ignite and burn your skin.

Do not smoke until the gel has completely dried on your skin.

Avoid getting this medication in your eyes, nose, mouth, rectum, or vagina. If this does happen, rinse with water. Do not use the medicine on sunburned, windburned, dry, chapped, irritated, or broken skin.

Avoid using other medications on the areas you treat with salicylic acid topical unless your doctor tells you to.

It is not likely that other drugs you take orally or inject will have an effect on topically applied salicylic acid. But many drugs can interact with each other. Tell each of your health care providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

UltraSal-ER (salicylic acid topical) side effects

Salicylic acid topical can cause a rare but serious allergic reaction or severe skin irritation. These reactions may occur just a few minutes after you apply the medicine, or within a day or longer afterward.

Stop using this medicine and get emergency medical help if you have signs of an allergic reaction: hives, itching; difficult breathing, feeling light-headed; swelling of your face, lips, tongue, or throat.

Stop using salicylic acid topical and call your doctor at once if you have:

  • severe headache, ringing in your ears, problems with hearing, thinking problems;

  • severe stomach pain, vomiting, or diarrhea;

  • a light-headed feeling, like you might pass out;

  • shortness of breath; or

  • severe burning, dryness, or irritation of the skin.

Common side effects may include:

  • minor skin irritation, rash, or peeling; or

  • changes in the color of treated skin (usually whitening).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Ultrasal-ER (28.5% Salicylic Acid Extended Release) Antiviral Film-Forming SolutionCarton Label Principal Display Panel

NDC 42783-323-10

Ultrasal-ER (28.5% Salicylic Acid Extended Release) Antiviral Film-Forming Solution

1/3 fl. oz. (10 mL)

Rx only

Ultrasal-ER 
salicylic acid solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:42783-323
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
salicylic acid (salicylic acid) salicylic acid 285 mg  in 1 mL
Packaging
# Item Code Package Description
1 NDC:42783-323-10 1 BOTTLE, WITH APPLICATOR in 1 CARTON
1 10 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 01/30/2014
Labeler - Elorac, Inc. (832590009)
Registrant - Elorac, Inc. (832590009)
Establishment
Name Address ID/FEI Operations
Swiss-American CDMO, LLC 080170933 manufacture(42783-323), analysis(42783-323), pack(42783-323), label(42783-323)
Establishment
Name Address ID/FEI Operations
Microconsult, Inc. 062183608 analysis(42783-323)
Revised: 08/2016   Elorac, Inc.
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