Label: DAYTIME MOISTURIZER- salicylic acid lotion
- NDC Code(s): 72644-633-01
- Packager: SGII, INC
- 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 September 16, 2020
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
- Warnings
- WHEN USING
- KEEP OUT OF REACH OF CHILDREN
-
Directions
Clean the skin thoroughly before applying this product
• Cover the entire affected area with a thin layer one to three times daily
• Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily
if needed or as directed by a doctor• If bothersome dryness or peeling occurs, reduce application to once a day or every other day
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Inactive Ingredients
Aqua/Water/Eau, Caprylic/CapricTriglyceride, Cetearyl Alcohol, Glycerin, Glycereth-26, Avocado (Perse
Gratissima) Oil, Jojoba (Simmondsia Chinensis) Seed Oil, Shea (Butyrospermum Parkii) Butter, Cetearyl Olivate, Sorbitan Olivate, Oliv
(Olea Europaea) Fruit Oil, Ammonium Acryloyldimethyltaurate/VP Copolymer, Coffee (Coffea Arabica) Seed Oil, Cucumber (Cucumis
Sativus) Extract, Willow Herb (Epilobium Angustifolium) Extract, Ginge (Zingiber Officinale) Root Extract, Seaweed (Corallina Officinalis) Extract, Kelp (Laminaria Digitata) Extract, Yeast (Saccharomyces Cerevisiae) Extract,Orchid (Orchis Morio) Flower Extract, Tripeptide-1, Tetrapeptide-17, Tocopherol, Sodium Hyaluronate, Panthenol, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Arginine, Dimethicone, Ceteth-10 Phosphate, Dicetyl Phosphate, Hydrolyzed Caesalpinia Spinosa Gum, Benzophenone-3, Ethylhexyl Methoxycinnamate, Cetyl Palmitate, Caprylyl Glycol, Sorbitan Palmitate, Propylene Glycol, Butylene Glycol, Caesalpinia Spinosa Gum, Ethylhexylglycerin, Hexylene Glycol, Bisabolol, Potassium Sorbate, Sodium Benzoate, BHT, Urea*, Glucosamine HCl, Sodium Metabisulfite, Citric Acid, Dextran, Phenoxyethanol, Parfum/Fragrance. *synthetic
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DAYTIME MOISTURIZER
salicylic acid lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72644-633 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 1 g in 100 g Inactive Ingredients Ingredient Name Strength SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM METABISULFITE (UNII: 4VON5FNS3C) GINGER (UNII: C5529G5JPQ) CETETH-10 PHOSPHATE (UNII: 4E05O5N49G) LEVOMENOL (UNII: 24WE03BX2T) LAMINARIA DIGITATA (UNII: 15E7C67EE8) TOCOPHEROL (UNII: R0ZB2556P8) PANTHENOL (UNII: WV9CM0O67Z) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N) CAESALPINIA SPINOSA RESIN (UNII: WL3883U2PO) CETYL PALMITATE (UNII: 5ZA2S6B08X) OCTINOXATE (UNII: 4Y5P7MUD51) OLIVE OIL (UNII: 6UYK2W1W1E) YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U) PREZATIDE (UNII: 39TG2H631E) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) HEXYLENE GLYCOL (UNII: KEH0A3F75J) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) SHEA BUTTER (UNII: K49155WL9Y) HYALURONATE SODIUM (UNII: YSE9PPT4TH) WATER (UNII: 059QF0KO0R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) AVOCADO OIL (UNII: 6VNO72PFC1) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) GLYCERIN (UNII: PDC6A3C0OX) GLYCERETH-26 (UNII: NNE56F2N14) JOJOBA OIL (UNII: 724GKU717M) CETEARYL OLIVATE (UNII: 58B69Q84JO) SORBITAN OLIVATE (UNII: MDL271E3GR) CUCUMBER JUICE (UNII: 61845009SP) ARGININE (UNII: 94ZLA3W45F) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) UREA (UNII: 8W8T17847W) GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) DEXTRAN 1 (UNII: I8LHQ0D645) PHENOXYETHANOL (UNII: HIE492ZZ3T) ARABICA COFFEE OIL (UNII: IK55HKE887) EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP (UNII: 08H094218D) CORALLINA OFFICINALIS (UNII: 4004498D06) ANACAMPTIS MORIO FLOWER (UNII: PT2C4RA48D) DIMETHICONE (UNII: 92RU3N3Y1O) OXYBENZONE (UNII: 95OOS7VE0Y) SORBITAN MONOPALMITATE (UNII: 77K6Z421KU) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72644-633-01 27 g in 1 BOTTLE; Type 0: Not a Combination Product 09/16/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 09/16/2020 Labeler - SGII, INC (070096792) Establishment Name Address ID/FEI Business Operations 220 LABORATORIES INC 783247950 manufacture(72644-633)
