Label: EVENING MOISTURIZER- salicylic acid cream
- NDC Code(s): 72644-635-01
- 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 Ingredient
- Purpose
- Uses
- Warnings
- WHEN USING
- KEEP OUT OF REACH OF CHILDREN
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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
Sodium Hyaluronate, Panthenol, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Arginine, Dimethicone, Ceteth-10 Phosphate, Dicetyl Phosphate, Hydrolyzed Caesalpinia Spinosa Gum, Phenoxyethanol, Cetyl Palmitate, Caprylyl Glycol, Sorbitan Palmitate, Propylene Glycol, Butylene Glycol, Caesalpinia Spinosa Gum, Ethylhexylglycerin, Hexylene Glycol, Bisabolol, Tetrasodium EDTA, Potassium Sorbate, Sodium Benzoate, Urea*, Glucosamine HCl, Sodium Metabisulfite, Citric Acid, Parfum/Fragrance. *synthetic
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
EVENING MOISTURIZER
salicylic acid creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72644-635 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 WATER (UNII: 059QF0KO0R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) GLYCERIN (UNII: PDC6A3C0OX) GLYCERETH-26 (UNII: NNE56F2N14) JOJOBA OIL (UNII: 724GKU717M) SHEA BUTTER (UNII: K49155WL9Y) OLIVE OIL (UNII: 6UYK2W1W1E) SORBITAN OLIVATE (UNII: MDL271E3GR) EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP (UNII: 08H094218D) GINGER (UNII: C5529G5JPQ) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) DIMETHICONE (UNII: 92RU3N3Y1O) SORBITAN MONOPALMITATE (UNII: 77K6Z421KU) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) CETETH-10 PHOSPHATE (UNII: 4E05O5N49G) CETYL PALMITATE (UNII: 5ZA2S6B08X) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) AVOCADO OIL (UNII: 6VNO72PFC1) CETEARYL OLIVATE (UNII: 58B69Q84JO) CUCUMBER JUICE (UNII: 61845009SP) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) LAMINARIA DIGITATA (UNII: 15E7C67EE8) YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U) CORALLINA OFFICINALIS (UNII: 4004498D06) ANACAMPTIS MORIO FLOWER (UNII: PT2C4RA48D) HYALURONATE SODIUM (UNII: YSE9PPT4TH) ARGININE (UNII: 94ZLA3W45F) DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N) EDETATE SODIUM (UNII: MP1J8420LU) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) HEXYLENE GLYCOL (UNII: KEH0A3F75J) SODIUM BENZOATE (UNII: OJ245FE5EU) GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY) SODIUM METABISULFITE (UNII: 4VON5FNS3C) FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) CAESALPINIA SPINOSA RESIN (UNII: WL3883U2PO) CAPRYLYL GLYCOL (UNII: 00YIU5438U) PANTHENOL (UNII: WV9CM0O67Z) PHENOXYETHANOL (UNII: HIE492ZZ3T) LEVOMENOL (UNII: 24WE03BX2T) UREA (UNII: 8W8T17847W) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72644-635-01 30 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(72644-635)
