NDC 11410-071 Proactiv Deep Cleansing Body Wash

Salicylic Acid

NDC Product Information

Proactiv Deep Cleansing Body Wash with NDC 11410-071 is a a human over the counter drug product labeled by The Proactiv Company Llc. The generic name of Proactiv Deep Cleansing Body Wash is salicylic acid. The product's dosage form is lotion/shampoo and is administered via topical form.

Labeler Name: The Proactiv Company Llc

Dosage Form: Lotion/shampoo - A lotion dosage form which has a soap or detergent that is usually used to clean the hair and scalp; it is often used as a vehicle for dermatologic agents.

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.

Proactiv Deep Cleansing Body Wash 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 2 g/100mL

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)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • CHROMIUM HYDROXIDE GREEN (UNII: RV8FT8XF5R)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • DISTEARYL PHTHALAMIC ACID (UNII: 5552GSZ9LI)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • HEXYLENE GLYCOL (UNII: KEH0A3F75J)
  • HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)
  • MENTHOL (UNII: L7T10EIP3A)
  • PARAFFIN (UNII: I9O0E3H2ZE)
  • PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • WATER (UNII: 059QF0KO0R)

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.
  • 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: The Proactiv Company Llc
Labeler Code: 11410
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: 02-01-2020 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.

Proactiv Deep Cleansing Body Wash Product Label Images

Proactiv Deep Cleansing Body Wash 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 2%

Purpose

Acne Treatment

Use

For the management 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.

Directions

  • 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 below.apply to dampened skin and gently massage.rinse thoroughly with warm waterpat dry.if bothersome dryness or peeling occurs, reduce application use.may need to shake product before use.

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Butylene Glycol, Camellia Sinensis Leaf Extract, Caprylyl Glycol, Cetyl Alcohol, Chromium Hydroxide Green, Cocamidopropyl Betaine, Disodium EDTA, Distearyl Phthalic Acid Amide, Ethylhexylglycerin, Fragrance, Hexylene Glycol, Jojoba Esters, Menthol, Paraffin, PEG-120 Methyl Glucose Dioleate, Phenoxyethanol, Sodium Chloride, Sodium Hydroxide, Sodium Methyl Cocoyl Taurate, Stearyl Alcohol, WaterQuestions or comments?Within US 1-800-950-4695

* Please review the disclaimer below.