NDC 50718-0034 Clear Acne Kit

Acne Kit

NDC Product Code 50718-0034

NDC 50718-0034-1

Package Description: 1 KIT in 1 CARTON * 1 BOTTLE in 1 CARTON (50718-0032-1) > 22 mL in 1 BOTTLE * 1 BOTTLE in 1 CARTON (50718-0033-1) > 50 mL in 1 BOTTLE * 1 BOTTLE in 1 CARTON (50718-0031-1) > 100 mL in 1 BOTTLE

NDC Product Information

Clear Acne Kit with NDC 50718-0034 is a a human over the counter drug product labeled by Kamedis. The generic name of Clear Acne Kit is acne kit. The product's dosage form is kit and is administered via form.

Labeler Name: Kamedis

Dosage Form: Kit - A packaged collection of related material.

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.

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.

  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • PURSLANE (UNII: M6S840WXG5)
  • CHLORPHENESIN (UNII: I670DAL4SZ)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • HEXYLENE GLYCOL (UNII: KEH0A3F75J)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • WATER (UNII: 059QF0KO0R)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • SQUALANE (UNII: GW89575KF9)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
  • COCO MONOETHANOLAMIDE (UNII: C80684146D)
  • LAUROYL LYSINE (UNII: 113171Q70B)
  • MYRISTIC ACID (UNII: 0I3V7S25AW)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SAPINDUS MUKOROSSI FRUIT (UNII: 66H9NW427Y)
  • SODIUM LAUROYL METHYL ISETHIONATE (UNII: II6VCD3S6R)
  • SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • EDETATE SODIUM (UNII: MP1J8420LU)
  • TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)
  • SODIUM COCOYL APPLE AMINO ACIDS (UNII: EB3U1PA61T)
  • METHYL GLUCOSE (UNII: QCF122NF3R)
  • (C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)
  • ALCOHOL (UNII: 3K9958V90M)
  • PHELLODENDRON AMURENSE BARK (UNII: PBG27B754G)
  • SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ)
  • CHLORPHENESIN (UNII: I670DAL4SZ)
  • CHRYSANTHEMUM INDICUM FLOWER (UNII: I6OER6U04L)
  • PURSLANE (UNII: M6S840WXG5)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • RHEUM PALMATUM ROOT (UNII: G025DAL7CE)
  • SANGUISORBA OFFICINALIS ROOT (UNII: 4NYV2HT01X)
  • PICEA ABIES WOOD (UNII: 72GZ8K8996)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • SARCOSINE (UNII: Z711V88R5F)
  • HEXASODIUM PHYTATE (UNII: ZBX50UG81V)
  • TROMETHAMINE (UNII: 023C2WHX2V)
  • WATER (UNII: 059QF0KO0R)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • CINNAMON BARK OIL (UNII: XE54U569EC)
  • HEXYLENE GLYCOL (UNII: KEH0A3F75J)
  • ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
  • ALCOHOL (UNII: 3K9958V90M)
  • ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
  • ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)
  • SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • PURSLANE (UNII: M6S840WXG5)
  • CHLORPHENESIN (UNII: I670DAL4SZ)
  • RHEUM PALMATUM ROOT (UNII: G025DAL7CE)
  • CHRYSANTHEMUM INDICUM FLOWER (UNII: I6OER6U04L)
  • DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • HEXYLENE GLYCOL (UNII: KEH0A3F75J)
  • PICEA ABIES WOOD (UNII: 72GZ8K8996)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • SARCOSINE (UNII: Z711V88R5F)
  • WATER (UNII: 059QF0KO0R)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • CINNAMON BARK OIL (UNII: XE54U569EC)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • HEXASODIUM PHYTATE (UNII: ZBX50UG81V)
  • SQUALANE (UNII: GW89575KF9)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • DOCOSANOL (UNII: 9G1OE216XY)
  • PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
  • CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
  • DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
  • NORI (UNII: 477TV3P5UX)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Kamedis
Labeler Code: 50718
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: 01-01-2018 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".

* Please review the disclaimer below.

Clear Acne Kit 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 1.0%

Salicylic acid 2.0%

Salicylic acid 2.0%

Purpose

Acne Treatment

Acne Treatment

Acne Treatment

Use

  • For the treatment of acne

  • For the treatment of acne

  • For the treatment of acne

Warnings

For external use only

For external use only

For external use only

When Using This Product

  • Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.Using other topical acne medication at the same time or immediately following the use of this product may increase dryness or irritation of the skin. If this occurs, only one medication at a time should be used, unless otherwise directed by a doctor.

  • Avoid unnecessary sun exposure and use sunscreen.Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.Using other topical acne medication at the same time or immediately following the use of this product may increase dryness or irritation of the skin. If this occurs, only one medication at a time should be used, unless otherwise directed by a doctor.

  • Avoid unnecessary sun exposure and use sunscreen.Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.Using other topical acne medication at the same time or immediately following the use of this product may increase dryness or irritation of the skin. If this occurs, only one medication at a time should be used, unless otherwise directed by a doctor.

Stop Use And Ask A Doctor

  • If irritation persists

  • If irritation persists

  • If irritation persists

Keep Out Of Reach Of Children

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

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

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

Directions

  • Wet face. Apply to hands, add water and work into lather. Gently massage all over face avoiding eye area. Rinse thoroughly and pat dry. Good for daily use.Cover the entire affected area with a thin layer one to three times daily.Because 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 doctor.If bothersome dryness or peeling occurs, reduce application to once a day or every other dayFor children under 10 years of age, consult your physician.

  • Cleanse the skin thoroughly before applying medication.Cover the entire affected area with a thin layer one to three times daily.Because 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 doctor.If bothersome dryness or peeling occurs, reduce application to once a day or every other day.For children under 10 years of age, consult your physician.

  • Cleanse the skin thoroughly before applying medication.Cover the entire affected area with a thin layer one to three times daily.Because 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 doctor.If bothersome dryness or peeling occurs, reduce application to once a day or every other day.For children under 10 years of age, consult your physician.

Inactive Ingredients

Benzyl Alcohol, Chlorphenesin, Cocamide MEA, Cocamidopropyl Betaine, Common Purslane (Portulaca Oleracea) Extract, Fragrance, Glycerin, Glyceryl Stearate SE, Hexylene Glycol, Hydrolyzed Jojoba Ester, Lauroyl Lysine, Methyl Glucose Caprate/ Caprylate/ Oleate, Myristic Acid, Propanediol, Salt (Sodium Chloride), Soapberry (Sapindus Mukurossi) Fruit Extract, Sodium Cocoyl Apple Amino Acids, Sodium Hydroxide, Sodium Lauroyl Methyl Isethionate, Sodium Methyl Cocoyl Taurate, Squalane, Stearic Acid, Tetrasodium EDTA, Trisodium Ethylenediamine Dissuccinate, Vitamin E (Tocopheryl Acetate), Water, Xanthan Gum.

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Alcohol, Amur Cork Tree (Phellodendron Amurense) Bark Extract, Baikal Skullcap (Scutellaria Baicalensis) Root Extract, Benzyl Alcohol, Capryloyl Glycine, Chinese Rhubarb (Rheum Palmatum ) Root Extract, Chlorphenesin, Chrysanthemum (Chrysanthemum Indicum) Flower Extract, Cinnamon (Cinnamomum Zeylanicum) Bark Extract, Common Purslane (Portulaca Oleracea) Extract, Fragrance, Glycerin, Great Burnet (Sanguisorba Officinalis) Root Extract, Hexylene Glycol, Norway Spruce (Picea Abis) Extract, Propanediol, Sarcosine, SD Alcohol 40-C, Sodium Phytate, Tromethamine, Water, Xanthan Gum

Alcohol, Arachidyl Alcohol, Arachidyl Glucoside, Ascorbyl Tetraisopalmitate, Baikal Skullcap (Scutellaria Baicalensis) Root Extract, Behenyl Alcohol, Benzyl Alcohol, Capryloyl Glycine, Carbomer, Cetyl Alcohol, Chlorphenesin, Chinese Rhubarb (Rheum Palmatum) Root Extract, Chrysanthemum (Chrysanthemum Indicum) Flower Extract, Cinnamon (Cinnamomum Zeylanicum) Bark Extract, Common Purslane (Portulaca Oleracea) Extract, Dicaprylyl Carbonate, Fragrance, Glucose, Glycerin, Hexylene Glycol, Norway Spruce (Picea Abis) Extract, Phenethyl Alcohol, Plankton Extract, Propanediol, Sarcosine, SD Alcohol 40-C, Shea Butter (Butyrospermum Parkii), Sodium Hydroxide, Sodium Phytate, Squalane, Stearyl Alcohol, Water, Xanthan Gum.

* Please review the disclaimer below.