NDC 69840-014 Yes To Tomatoes Acne Fighting Spot Treatment

Salicylic Acid

NDC Product Code 69840-014

NDC 69840-014-05

Package Description: 1 BOTTLE, WITH APPLICATOR in 1 BOX > 15 mL in 1 BOTTLE, WITH APPLICATOR

NDC Product Information

Yes To Tomatoes Acne Fighting Spot Treatment with NDC 69840-014 is a a human over the counter drug product labeled by Yes To, Inc.. The generic name of Yes To Tomatoes Acne Fighting Spot Treatment is salicylic acid. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Yes To, Inc.

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.

Yes To Tomatoes Acne Fighting Spot Treatment 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 20 mg/mL

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.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • WATER (UNII: 059QF0KO0R)
  • HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • ALLANTOIN (UNII: 344S277G0Z)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)
  • SOLANUM LYCOPERSICUM (UNII: 0243Q4990L)
  • TEA TREE OIL (UNII: VIF565UC2G)
  • COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
  • ACACIA (UNII: 5C5403N26O)
  • OCTYLDODECANOL (UNII: 461N1O614Y)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • DICAPRYLYL ETHER (UNII: 77JZM5516Z)
  • C14-22 ALCOHOLS (UNII: B1K89384RJ)
  • ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
  • BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • DOCOSANOL (UNII: 9G1OE216XY)
  • C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)
  • ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
  • .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • .ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)
  • GINGER (UNII: C5529G5JPQ)

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: Yes To, Inc.
Labeler Code: 69840
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: 06-01-2019 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: 12-31-2020 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Yes To Tomatoes Acne Fighting Spot Treatment Product Label Images

Yes To Tomatoes Acne Fighting Spot Treatment 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

Other

Drug Facts

Active Ingredient

Salicylic Acid 2%

Purpose

Acne Treatment

Uses

For the treatment of acne

Warnings

  • For external use onlyAvoid contact with the eyes.

When Using This Product

  • Skin irritation 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.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Clean the skin thoroughly before applying this productcover the entire affected area with a thin layer using the rollerball applicator one to three times dailybecause excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctorif bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Sensitivity Test For A New User

Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above.

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Water (Aqua), Hamamelis Virginiana (Witch Hazel) Water, Coco-Caprylate, Acacia Senegal Gum, Octyldodecanol, Xanthan Gum, Propanediol, Dicaprylyl Ether, C14-22 Alcohols, Arachidyl Alcohol, Biosaccharide Gum-1, Tocopheryl Acetate, Solanum Lycopersicum (Tomato) Extract, Charcoal Powder, Zingiber Officinale (Ginger) Root Juice, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Glycerin, Sodium Hydroxide, Ethylhexyglycerin, Allantoin, Bisabolol, Behenyl Alcohol, C12-20 Alkyl Glucoside, Arachidyl Glucoside, Phenoxyethanol, Fragrance (Parfum), Benzyl Benzoate, Limonene, Butylphenyl Methylpropional, Coumarin.

Questions?

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