NDC 69840-023 Yes To Tomatoes Detoxifying Overnight Moisturizer

Salicylic Acid

NDC Product Information

Yes To Tomatoes Detoxifying Overnight Moisturizer with NDC 69840-023 is a a human over the counter drug product labeled by Yes To Incorporated. The generic name of Yes To Tomatoes Detoxifying Overnight Moisturizer is salicylic acid. The product's dosage form is cream and is administered via topical form.

Labeler Name: Yes To Incorporated

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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 Detoxifying Overnight Moisturizer 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/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.

  • WATER (UNII: 059QF0KO0R)
  • GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • CETEARYL OLIVATE (UNII: 58B69Q84JO)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)
  • COCOA BUTTER (UNII: 512OYT1CRR)
  • OCTYLDODECANOL (UNII: 461N1O614Y)
  • SORBITAN OLIVATE (UNII: MDL271E3GR)
  • JOJOBA OIL (UNII: 724GKU717M)
  • GLYCERYL MONOCAPRYLOCAPRATE (UNII: G7515SW10N)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • AVOCADO OIL (UNII: 6VNO72PFC1)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • DOCOSANOL (UNII: 9G1OE216XY)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)
  • WATERMELON (UNII: 231473QB6R)
  • ALCOHOL (UNII: 3K9958V90M)
  • SOLANUM LYCOPERSICUM FRUITING TOP (UNII: X636CG4BH0)
  • GINKGO (UNII: 19FUJ2C58T)
  • CUCURBITA PEPO WHOLE (UNII: 48V44WX64I)
  • ASPALATHUS LINEARIS WHOLE (UNII: O17JQA1A9Z)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • MATRICARIA CHAMOMILLA FLOWERING TOP (UNII: 3VNC7T6Z02)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • PENTAERYTHRITYL TETRAETHYLHEXANOATE (UNII: XJ7052W897)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • COCONUT OIL (UNII: Q9L0O73W7L)

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 Incorporated
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: 01-01-2021 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: 12-31-2021 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 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’.

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Yes To Tomatoes Detoxifying Overnight Moisturizer Product Label Images

Yes To Tomatoes Detoxifying Overnight Moisturizer 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 0.5%

Purpose

Acne treatment

Use

For the treatment of acne.

Warnings

For external use only.

When Using This Product

  • Skin irritation and dryness is more likely to occur if you use another topical medication at the same time. If irritation occurs, only use one topical medication at a time.avoid contact with eyes. If contact occurs, flush thoroughly with water.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If 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 once daily at nightif bothersome dryness or peeling occurs, reduce application to every other day if needed or as directed by a doctor.

Sensitivity Test For A New User

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

Inactive Ingredients

Water (Aqua), Cocos Nucifera (Coconut) Oil, Aloe Barbadensis Leaf Juice, Glyceryl Stearate, Butyrospermum Parkii (Shea) Butter, Glycerin, Zea Mays (Corn) Starch, Propanediol, Behenyl Alcohol, Cetearyl Olivate, Theobroma Cacao (Cocoa) Seed Butter, Octyldodecanol, Sorbitan Olivate, Simmondsia Chinensis (Jojoba) Seed Oil, Charcoal Powder, Solanum Lycopersicum (Tomato) Fruit Extract, Persea Gratissima (Avocado) Oil, Aspalathus Linearis Extract, Citrullus Lanatus (Watermelon) Fruit Extract, Chamomilla Recutita (Matricaria) Extract, Cucurbita Pepo (Pumpkin) Fruit Extract, Ginkgo Biloba Leaf Extract, Tocopheryl Acetate, Xanthan Gum, Sodium Hydroxide, Stearic Acid, Alcohol, Pentaerythrityl Tetraethylhexanoate, Glyceryl Caprylate, Phenoxyethanol, Ethylhexylglycerin, Fragrance (Parfum), Benzyl Benzoate, Coumarin, Butylphenyl Methylpropional.

Questions?

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