Label: PURESKIN SEBORRHEIC DERMATITIS ECZEMA CREAM- seborrheic dermatitis eczema cream cream
- NDC Code(s): 83565-001-01
- Packager: Stellans 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 July 8, 2023
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Use
- Warnings
- Do not use
- When Using
- Stop Use
- Ask Doctor
- Keep Out Of Reach Of Children
- Directions
- Other information
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Inactive ingredients
Glycerin, Sodium Hyaluronate, Salicylic Acid,
Rhinacanthus Nasutus Leaf, Heba Violae, Euphorbia Hirta L., Murraya Exotica L., Mentha Canadensis L., Cortexdictamnil, Sophora Flavescens Root, Cnidium Monnieri (L.) Cusson, Smilax Glabra Rhizome, Mosla Cavaleriei H.Lv.,, Phellodendron Amurense Rupr., Fischereuphorbia Root, Gleditsia Sinensis Thorn, Kochia Scoparia, Chlorhexidine Acetate, Stemona Tuberosa Lour - Questions
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PURESKIN SEBORRHEIC DERMATITIS ECZEMA CREAM
seborrheic dermatitis eczema cream creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83565-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I) KETOCONAZOLE 0.5 g in 100 mL Inactive Ingredients Ingredient Name Strength RHINACANTHUS NASUTUS LEAF (UNII: 97OQD55S9I) DICTAMNUS DASYCARPUS ROOT (UNII: 6153LEN214) MOSLA CAVALERIEI WHOLE (UNII: 05O8B64OS2) GLEDITSIA SINENSIS THORN (UNII: 26LKE578NY) CHLORHEXIDINE ACETATE (UNII: 5908ZUF22Y) SALICYLIC ACID (UNII: O414PZ4LPZ) EUPHORBIA HIRTA LEAF (UNII: 243K8QF0MS) MURRAYA PANICULATA LEAFY TWIG (UNII: VO9X9681W9) MENTHA CANADENSIS WHOLE (UNII: J1BO4MHT2L) CNIDIUM MONNIERI WHOLE (UNII: GYR30735RE) BASSIA SCOPARIA FRUIT (UNII: 04W97Z676Y) SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K) SMILAX GLABRA TUBER (UNII: PES3YXA3LR) STEMONA TUBEROSA WHOLE (UNII: 9373ZOT316) PHELLODENDRON AMURENSE WHOLE (UNII: 3OZN5NGR9L) EUPHORBIA FISCHERIANA ROOT (UNII: R4DRG4762Y) GLYCERIN (UNII: PDC6A3C0OX) HYALURONATE SODIUM (UNII: YSE9PPT4TH) VIOLA ADUNCA WHOLE (UNII: 26Z8E4RZ3Q) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83565-001-01 100 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/07/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M005 07/07/2023 Labeler - Stellans Inc. (111157321) Establishment Name Address ID/FEI Business Operations Stellans Inc. 111157321 label(83565-001) , manufacture(83565-001)