Stay Pure Acne Treatment
FDA Label NDC 65447-377

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Aloette for the product Stay Pure Acne Treatment (NDC 65447-377). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, medicinal ingredient/active ingredient, purpose, uses, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick 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 practitioner
  • Avoid 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 medication

  • Cover the entire affected area with a thin layer one to three times daily or as directed by a health care professional
  • Because 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

Question Or Comments?

Call 1.800.Aloette or visit www.Aloette.com

Principal Display Panel - 15 Ml Tube Carton

aloeclear™

3

Stay Pure

Acne Treatment Lotion

Salicylic Acid 2.0% w/w
NPN 80054497
0.5 FL OZ/15 mL

TREAT

Principal Display Panel (15 mL Tube Carton)

Principal Display Panel (15 mL Tube Carton)

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