NDC 69366-409 Clearing Cleanser 0.5% Salicylic Acid Acne Treatment

Salicylic Acid

NDC Product Code 69366-409

NDC Code: 69366-409

Proprietary Name: Clearing Cleanser 0.5% Salicylic Acid Acne Treatment Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.


Code Structure
  • 69366 - The Honest Company, Inc.
    • 69366-409 - Clearing Cleanser

NDC 69366-409-14

Package Description: 1 BOTTLE in 1 CARTON > 140 g in 1 BOTTLE

NDC Product Information

Clearing Cleanser 0.5% Salicylic Acid Acne Treatment with NDC 69366-409 is a a human over the counter drug product labeled by The Honest Company, Inc.. The generic name of Clearing Cleanser 0.5% Salicylic Acid Acne Treatment is salicylic acid. The product's dosage form is gel and is administered via topical form.

Labeler Name: The Honest Company, Inc.

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

Product Type: Human Otc Drug Additional informationCallout TooltipWhat 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.


Clearing Cleanser 0.5% Salicylic Acid Acne Treatment Active Ingredient(s)

Additional informationCallout TooltipWhat 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 g/100g

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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)
  • COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)
  • SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)
  • LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
  • ISOPENTYLDIOL (UNII: 19NOL5474Q)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • VACCINIUM MYRTILLUS ANTHOCYANOSIDES (UNII: R911H793SU)
  • BERGAMOT OIL (UNII: 39W1PKE3JI)
  • AZADIRACHTA INDICA LEAF (UNII: HKY915780T)
  • LEMON (UNII: 24RS0A988O)
  • ORANGE (UNII: 5EVU04N5QU)
  • ACER SACCHARUM BARK/SAP (UNII: Z120VL0KAC)
  • BALSAM PERU OIL (UNII: DIK0395679)
  • ROSA CANINA FRUIT (UNII: 3TNW8D08V3)
  • CARDAMOM OIL (UNII: JM0KJ091HZ)
  • CINNAMON LEAF OIL (UNII: S92U8SQ71V)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • OPUNTIA FICUS-INDICA (UNII: 23Z87HTQ6P)
  • PHYTATE SODIUM (UNII: 88496G1ERL)
  • GLUCONOLACTONE (UNII: WQ29KQ9POT)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • CALCIUM GLUCONATE (UNII: SQE6VB453K)
  • VANILLIN (UNII: CHI530446X)
  • BENZALDEHYDE (UNII: TA269SD04T)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: The Honest Company, Inc.
Labeler Code: 69366
FDA Application Number: part333D Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 01-20-2019 Additional informationCallout TooltipWhat 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: 12-31-2019 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Information for Patients

Salicylic Acid Topical

Salicylic Acid Topical is pronounced as (sal'' i sil' ik as' id)

Why is salicylic acid topical medication prescribed?
Topical salicylic acid is used to help clear and prevent pimples and skin blemishes in people who have acne. Topical salicylic acid is also used to treat skin conditions ...
[Read More]

* Please review the disclaimer below.

Clearing Cleanser 0.5% Salicylic Acid Acne Treatment Product Label Images

Clearing Cleanser 0.5% Salicylic Acid Acne 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

Active Ingredient

Salicylic Acid 0.5%

Purpose

Acne Treatment Gel

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 acne medication at the same time. If irritation occurs, only use one topical acne medication at a time. •avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Allergy Alert.

Do not use this product if you have a known allergy to Salicylic Acid.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • •Use twice daily. Wet face, then mix 1 to 2 pumps with water and work product into a lather. Massage onto face avoiding eye area. Rinse thoroughly with water. •Because excessive drying of the skin may occur, start with once a day working up to two or as directed by a doctor.

Inactive Ingredients

Water (Aqua), Sodium Laurylglucosides Hydroxypropylsulfonate, Cocamidopropyl Hydroxysultaine, Sodium Methyl Cocoyl Taurate, Lauryl Glucoside, Isopentyldiol, Sodium Chloride, Vaccinium Myrtillus Fruit Extract, Saccharum Officinarum Extract, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Melia Azadirachta Leaf Extract, Citrus Limon (Lemon) Fruit Extract, Citrus Aurantium Dulcis (Orange) Fruit Extract, Acer Saccharum (Sugar Maple) Extract, Myroxylon Pereirae (Balsam Peru) Oil, Rosa Canina Fruit Extract, Elettaria Cardamomum Seed Oil, Cinnamomum Zeylanicum Leaf Oil, Glycerin, Opuntia Ficus-Indica Extract, Sodium Phytate, Gluconolactone, Caprylic/Capric Triglyceride, Calcium Gluconate, Vanillin, Benzaldehyde, Sodium Benzoate, Limonene.

Other Information

Store in dry, cool conditions.

* Please review the disclaimer below.

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