NDC 45634-100 Acne Relief Maximum Strength Spot Gel

NDC Product Code 45634-100

NDC CODE: 45634-100

Proprietary Name: Acne Relief Maximum Strength Spot Gel What 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.

NDC Code Structure

  • 45634 - Nv Perricone Llc
    • 45634-100 - Acne Relief Maximum Strength Spot Gel

NDC 45634-100-01

Package Description: 1 TUBE in 1 PACKAGE > 14.1 g in 1 TUBE

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Acne Relief Maximum Strength Spot Gel with NDC 45634-100 is a product labeled by Nv Perricone Llc. The product's dosage form is and is administered via form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 346298.

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)
  • ALCOHOL (UNII: 3K9958V90M)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SUCROSE (UNII: C151H8M554)
  • CITRULLINE (UNII: 29VT07BGDA)
  • HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)
  • UREA (UNII: 8W8T17847W)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • LACTIC ACID (UNII: 33X04XA5AT)
  • TEA TREE OIL (UNII: VIF565UC2G)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
  • SUCCINIC ACID (UNII: AB6MNQ6J6L)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)

Product Labeler Information

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

Labeler Name: Nv Perricone Llc
Labeler Code: 45634
Start Marketing Date: 08-01-2019 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: I - INACTIVATED, the listing data was inactivated by the FDA. 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".

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Acne Relief Maximum Strength Spot Gel Product Label Images

Acne Relief Maximum Strength Spot Gel 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

Otc - Active Ingredient

Active IngredientSalicylic Acid 2.0%

Otc - Purpose

PurposeAcne Treatment

Indications & Usage

Use■ For the treatment of acne.

Warnings

Warnings■ For external use only. ■When Using This Product skin irritationand dryness are more likely to occur if youuse another topical acne medication atthe same time. ■ If irritation occurs, onlyuse one topical acne medication at atime. ■ Keep out of reach of children.If swallowed, get medical help or contacta Poison Control Center right away.

Dosage & Administration

Directions ■ Clean the skin thoroughlybefore applying this product. ■ Cover theentire affected area with a thin layer oneto three times daily. ■ Because excessivedrying of the skin may occur, start with oneapplication daily, then gradually increaseto two or three times daily if needed or asdirected by a doctor. ■ If bothersome drynessor peeling occurs, reduce applicationto once a day or every other day. ■ SensitivityTest for a New User Apply productsparingly to one or two small affectedareas during the first 3 days. If no discomfortoccurs, follow the directions stated above.

Inactive Ingredient

Inactive Ingredients Water/Aqua/Eau,SD Alcohol 40-B, Propanediol, HamamelisVirginiana (Witch Hazel) Water, Glycerin,Sucrose, Citrulline, Hydroxyethylcellulose,Urea, Panthenol, Lactic Acid, MelaleucaAlternifolia (Tea Tree) Leaf Oil, Sodium Hydroxide,Tetrasodium Glutamate Diacetate,Succinic Acid, Alcohol, Polysorbate 20

Otc - Questions

Questions1-888-823-7837

Product Package

ACNE RELIEFMaximum Strength Spot GelMinimizes blemishes & helps preventfuture breakoutsPerricone MDACNE RELIEFMaximumStrengthSpot GelSalicylic AcidAcne Treatment90 DAY SUPPLYLactic & Succinic Acids,Citrulline, Tea Tree Oil℮ Net Wt 0.5oz / 14.1 gKEYINGREDIENTSLactic & SuccinicAcids: Attack Acne-Causing BacteriaThese short-chain fattyacids help quickly shrinkblemishes by workingalongside salicylic acidto attack acne-causingbacteria for a healthierskin microbiome. Theyalso provide gentle yeteffective exfoliation forsmoother, more even-lookingskin.Citrulline: Fight Irritation& Visibly ReduceRedness First discoveredin watermelon,this alpha-amino acidvisibly calms skin fora clearer, more even-lookingcomplexion.Nourishing & soothing,it is an ideal way tocounteract the irritatingeffects of antiacneingredients.Tea Tree Oil: Cleanse,Clarify & Soothe Thispowerful essential oilhelps visibly reduceredness & calm skin.It easily penetratesskin’s surface, featuresa light, refreshing scentsimilar to eucalyptus& has been used forcenturies in traditionalAustralian medicine.This maximum strength invisible gel worksovertime to reduce blemishes & preventfuture breakouts by killing acne-causingbacteria, unclogging pores & absorbingexcess oil without over-drying.Dist. By: NV Perricone LLC, San Francisco,CA 94111. Made in USA of foreign anddomestic components. 6511991 888 823 7837 perriconemd.comExpiration &Lot Code areaOuter BoxTuberege

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