NDC 65447-377 Stay Pure Acne Treatment

NDC Product Code 65447-377

NDC CODE: 65447-377

Proprietary Name: Stay Pure Acne Treatment 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

  • 65447 - Aloette

NDC 65447-377-00

Package Description: 1 TUBE in 1 CARTON > 15 mL in 1 TUBE

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

NDC Product Information

Stay Pure Acne Treatment with NDC 65447-377 is a product labeled by Aloette. 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: 103568.

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)
  • WATER (UNII: 059QF0KO0R)
  • ALCOHOL (UNII: 3K9958V90M)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • STARCH, TAPIOCA (UNII: 24SC3U704I)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • CHAMOMILE (UNII: FGL3685T2X)
  • MUSKMELON (UNII: ZV095H5633)
  • MASOPROCOL (UNII: 7BO8G1BYQU)
  • TEA TREE OIL (UNII: VIF565UC2G)
  • LEVOMENOL (UNII: 24WE03BX2T)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • RICE BRAN (UNII: R60QEP13IC)
  • LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
  • POLYQUATERNIUM-28 (1100000 MW) (UNII: 6M8B654MEQ)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Product Labeler Information

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

Labeler Name: Aloette
Labeler Code: 65447
Start Marketing Date: 01-01-2015 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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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.

Stay Pure Acne Treatment Product Label Images

Stay Pure 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

Other

Drug Facts

Distributed by Aloette Cosmetics Inc. Atlanta, GA 30327

Medicinal Ingredient/Active Ingredient

Salicylic Acid 2.0% w/w

Purpose

Acne Medication

Uses

For the treatment of acne.

Warnings

For external use only

Otc - When Using

  • When using this product with other topical acne medications at the same time or immediately following use of this product, may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a health care practitionerAvoid contact with eyes; If contact occurs, rinse with water to remove

Otc - Stop Use

  • Discontinue use if excessive skin irritation develops or increases. If irritation persists, consult a health care practitioner.

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

  • Cleanse the skin thoroughly before applying the medicationCover the entire affected area with a thin layer one to three times daily or as directed by a health care professionalBecause excessive drying of the skin may occur, start with one application daily and then gradually increase to two or three times daily if needed. If bothersome dryness or peeling occurs, reduce application to once a day or every other day.Keep carton for additional directions and warning information.

Non-Medicinal Ingredients/Inactive Ingredients

ALOE BARBADENSIS LEAF JUICE, AQUA, ALCOHOL DENAT., GLYCERIN, TAPIOCA STARCH, CYCLOPENTASILOXANE, DIMETHICONE, DICAPRYLYL CARBONATE, AMMONIUM ACRYLOYLDIMETHYLTA URATE/VP COPOLYMER, ALOE BARBADENSIS LEAF EXTRACT, BUTYROSPERMUM PARKII (SHEA) BUTTER, CAMELIA SINENSIS EXTRACT, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT, SUPEROXIDE DISMUTASE, NORDIHYDROGUAIARE TIC ACID, MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL, BISABOLOL, MALTODEXTRIN, ORYZA SATIVA (RICE) BRAN EXTRACT, LAURYL GLUCOSIDE, POLYQUATERNIUM-28, PHENOXYETHANOL, ETHYLHEXYLGLYCERIN

* Please review the disclaimer below.