NDC 61354-013 Mist

Salicylic Acid

NDC Product Code 61354-013

NDC 61354-013-01

Package Description: 1 BOTTLE in 1 CARTON > 100 mg in 1 BOTTLE

NDC Product Information

Mist with NDC 61354-013 is a a human over the counter drug product labeled by Oxygen Development, Llc. The generic name of Mist is salicylic acid. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Oxygen Development, Llc

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.

Mist 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 .5 mg/100mg

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.

  • LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
  • MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
  • WATER (UNII: 059QF0KO0R)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SALIX ALBA BARK (UNII: 205MXS71H7)
  • ROSA DAMASCENA FLOWER (UNII: JWB78P295A)
  • ACHILLEA MILLEFOLIUM FLOWER (UNII: YQR8R0SQEA)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
  • CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)

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: Oxygen Development, Llc
Labeler Code: 61354
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: 03-09-2021 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.

Mist 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.... 0.5%

Purpose

Acne Treatment

Use

Use for treatment of acne

Warnings

For external use only

Contact With Eyes

Avoid contact with eyes

Otc - When Using

When using this product, skin irritation and dryness is more likely to occur if using more than one topical acne medication at a time. If irritation occurs, limit use to one topical acne medication at a time.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, seek medical help or contact Poison Control right away.

Directions

Holding about six inches away from the face, spritz generously onto a clean, dry face and neck. Use both AM and PM after cleaning and before applying serums, moisturizers, and SPF.

Inactive Ingredients

Water/Aqua, Sodium Benzoate, Sodium Polyacrylate, Caprylyl/Capryl Glucoside, Potassium Sorbate, Eucalyptus Globulus Leaf Oil, Glycerin, Salix Alba (Willow) Bark Extract, Rosa Damascena Flower Extract, Citric Acid, achillea Milefolium Flower Extract, Glucose, Leuconostoc/Radish Root Ferment Filtrate, Melaleuca Alternifolia (Tea Tree) Leaf Oil.

Primary Package

Bottle

* Please review the disclaimer below.