NDC 49035-934 Quick Action

Salicylic Acid

NDC Product Code 49035-934

NDC CODE: 49035-934

Proprietary Name: Quick Action What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Salicylic Acid What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used on the skin to treat common skin and foot (plantar) warts. Salicylic acid helps cause the wart to gradually peel off. This medication is also used to help remove corns and calluses. This product should not be used on the face or on moles, birthmarks, warts with hair growing from them, or genital/anal warts. Salicylic acid is a keratolytic. It belongs to the same class of drugs as aspirin (salicylates). It works by increasing the amount of moisture in the skin and dissolving the substance that causes the skin cells to stick together. This makes it easier to shed the skin cells. Warts are caused by a virus. Salicylic acid does not affect the virus.

NDC Code Structure

NDC 49035-934-83

Package Description: 200 mL in 1 TUBE

NDC Product Information

Quick Action with NDC 49035-934 is a a human over the counter drug product labeled by Equate. The generic name of Quick Action is salicylic acid. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Equate

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.

Quick Action 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.

  • SALICYLIC ACID 2 g/100mL

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.

  • WATER (UNII: 059QF0KO0R)
  • SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • LAURETH-3 (UNII: F32E4CB0UJ)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • COCONUT ACID (UNII: 40U37V505D)
  • SODIUM ISETHIONATE (UNII: 3R36J71C17)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • LAVANDULA ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)
  • HELICHRYSUM ITALICUM FLOWER (UNII: P62Y550X24)
  • CISTUS MONSPELIENSIS WHOLE (UNII: T2OG06826L)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)

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: Equate
Labeler Code: 49035
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: 06-21-2017 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: 12-31-2021 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".

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Quick Action Product Label Images

Quick Action 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 2%

Purpose

Acne medication

Uses

For the treatment of acne

Warnings

For external use only

When Using This Product

  • Skin iritation and dryness is more likely to occur if you use another topical acne medication at the same time.  If irritation occurs, only use one topical acne medication at a time.

Keep Out Of Reach Of Children

If swallowed get medical help or contract a Poison Control Center right away

Directions

  • Wet face, apply to hand, massage face gently.  Rinse well.  Use up to twice dailyavoid contact with eyes.  If contact occurs, flush thoroughly with water.

Inactive Ingredients

Water, sodium cocoyl isethionate, cetearyl alcohol, laureth-3, glycerin, coconut acid, sodium isethionate, sodium hydroxide, fragrance, Lavandula stoechas extract, Helichrysum italicum extract, Cistus monspeliensis extract, disodium EDTA

Questions?

1-888-287-1915

Disclaimer

Satisfaction guaranteed-Or we'll replace it or give you your money back.  For Questions or comments or to report an undesired reaction or side effect, please call 1-888-287-1915This product is not manufactured or distributed by Reckitt Benckser, distributor of Clearasil ULTRA Rapid Action Daily Face Wash.

Adverse Reactions Section

DISTRIBUTED BY:Wal-Mart Stores, Inc.,Bentonville, AR 72716580.000/580AA

* Please review the disclaimer below.