Label: STAY PURE ACNE TREATMENT- salicylic acid lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 65447-377-00 - Packager: Aloette
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated December 27, 2019
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Medicinal Ingredient/Active Ingredient
- Purpose
- Uses
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Warnings
For external use only
- 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
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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.
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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?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 15 mL Tube Carton
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INGREDIENTS AND APPEARANCE
STAY PURE ACNE TREATMENT
salicylic acid lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65447-377 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid 20 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65447-377-00 1 in 1 CARTON 01/01/2015 1 15 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part333D 01/01/2015 Labeler - Aloette (831761320)
