Label: SEI BELLA CLARITY CLEAR ACNE ALL-OVER CLEARING SERUM CLEANSING SERUM- salicylic acid soap
- NDC Code(s): 54473-400-01
- Packager: Melaleuca, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 1, 2024
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- Active Ingredient
- Purpose
- INDICATIONS & USAGE
- Warnings
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions
- Cleanse and tone skin thoroughly before application
- Cover the entire affected area with a thin layer
- Use morning and night
- If excessive drying of the skin occurs, start with one application daily and then gradually increase if needed
- If bothersome peeling or dryness occurs, reduce application to once a day or every other day
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INACTIVE INGREDIENT
1,2 hexanediol, acetamidoethoxyethanol, albatrellus confluens (mushroom) extract, aqua (water/eau), bakuchiol, caprylhydroxamic acid, caprylyl glycol, chlorella vularis (plankton) extract, citric acid, cyclopentasiloxane, dimethicone, ethylhexylglycerin, glycerin, lecithin, lysolecithin, niacinamide, panthenol, PEG/PPG-18/18 dimethicone, phenethyl alcohol, phytic acid, propanediol, pullulan, sclerotium gum, sodium polyacrylate, tocopheryl acetate, tremella fuciformis (silver ear mushroom) sporocarp extract, trideceth-6, trisodium ethylenediamine disuccinate, xanthan gum
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SEI BELLA CLARITY CLEAR ACNE ALL-OVER CLEARING SERUM CLEANSING SERUM
salicylic acid soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54473-400 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 0.6 g in 30 mL Inactive Ingredients Ingredient Name Strength 1,2-HEXANEDIOL (UNII: TR046Y3K1G) DIMETHICONE (UNII: 92RU3N3Y1O) TREMELLA FUCIFORMIS FRUITING BODY (UNII: GG8N28393G) CAPRYLYL GLYCOL (UNII: 00YIU5438U) NIACINAMIDE (UNII: 25X51I8RD4) PULLULAN (UNII: 8ZQ0AYU1TT) BAKUCHIOL (UNII: OT12HJU3AR) XANTHAN GUM (UNII: TTV12P4NEE) PROPANEDIOL (UNII: 5965N8W85T) PHENYLETHYL ALCOHOL (UNII: ML9LGA7468) FYTIC ACID (UNII: 7IGF0S7R8I) TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q) WATER (UNII: 059QF0KO0R) BETASIZOFIRAN (UNII: 2X51AD1X3T) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) TRIDECETH-6 (UNII: 3T5PCR2H0C) CHLORELLA VULGARIS (UNII: RYQ4R60M02) GLYCERIN (UNII: PDC6A3C0OX) PANTHENOL (UNII: WV9CM0O67Z) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) LYSOPHOSPHATIDYLCHOLINE, SOYBEAN (UNII: CQD833204Z) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) ALBATRELLUS CONFLUENS FRUITING BODY (UNII: 7UVG8A4DP0) SOYBEAN LECITHIN (UNII: 1DI56QDM62) ACETAMIDOETHOXYETHANOL (UNII: LVX2APC4XR) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54473-400-01 30 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product 01/01/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M006 01/01/2024 Labeler - Melaleuca, Inc. (139760102) Establishment Name Address ID/FEI Business Operations Melaleuca, Inc. 079711683 manufacture(54473-400)