Label: JUMISO NO PAIN NO GAIN AC CURE SPOT- salicylic acid cream
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Contains inactivated NDC Code(s)
NDC Code(s): 73058-001-01, 73058-001-02 - Packager: HELLO SKIN Co.,Ltd.
- 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 April 18, 2019
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
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WARNINGS
For external use only
When using this product, skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time. avoid contact with eyes. If contact occurs, flush thoroughly with water.People with allergy to aspirin will react poorly to the Salicylic Acid.
- KEEP OUT OF REACH OF CHILDREN
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INACTIVE INGREDIENT
Water, Butylene Glycol, Silica, Niacinamide, Glycerin, Lithospermum Erythrorhizon Root Oil, Caprylic/Capric Triglyceride, Glyceryl Stearate, Macadamia Integrifolia Seed Oil, Carthamus Tinctorius (Safflower) Seed Oil, Limnanthes Alba (Meadowfoam) Seed Oil, Argania Spinosa Kernel Oil, Sodium Hyaluronate, Orbignya Oleifera Seed Oil, Glyceryl Stearate, PEG-100 Stearate, Polysorbate 60, Cetearyl Alcohol, Belamcanda Chinensis Root Extract, Sorbitan Monostearate, Propylene Glycol, Octanediol, Stearic acid, Bacopa Monniera Extract, Carbomer, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Triethanolamine, 1,2-Hexandiol, Ethylhexylglycerin, Allantoin, Dimethyl Sulfone, Alcohol, Phellodendron Amurense Bark Extract, Coptis Chinensis Root Extract, Aloe Barbadensis Leaf Extract, Luffa Cylindrica Fruit Extract, Citrus grandis (grapefruit) seed extract, Tocopheryl Acetate, Centella Asiatica Extract, Dipotassium Glycyrrhizate, Polyglutamic acid, Tocopherol, Hydrogenated Lecithin, Adenosine, Ceramide NP, Disodium EDTA, Camellia Sinensis Leaf Extract, Polygonum Cuspidatum Root Extract, Scutellaria Baicalensis Root Extract, Maltodextrin / Sodium Starch Octenylsuccinate, Rosmarinus Officinalis (Rosemary) Leaf Extract, PEG-10 Rapeseed sterol, Hydroxyethylcellulose, Citrus Aurantium Bergamia (Bergamot) Leaf Extract, Lavandula Angustifolia (Lavender) Flower Extract, Rosa Centifolia Flower Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Calcium Pantothenate, Artemisia princeps extract, Dipropylene Glycol, Methionine, Serine, Histidine, Hydroxyethylethylcelluose, Chamomilla Recutita (matricaria) Flower Extract, Sodium Ascorbyl Phosphate, Glyceryl Stearate, Glycereth-20, Portulaca Oleracea Extract, Dryopteris Filix-Mas Root Extract, Phenoxyethanol, Pyridoxine HCl
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
JUMISO NO PAIN NO GAIN AC CURE SPOT
salicylic acid creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73058-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 0.0015 g in 15 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) NIACINAMIDE (UNII: 25X51I8RD4) GLYCERIN (UNII: PDC6A3C0OX) LITHOSPERMUM ERYTHRORHIZON ROOT (UNII: 9I70D8O47I) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) MACADAMIA OIL (UNII: 515610SU8C) SAFFLOWER OIL (UNII: 65UEH262IS) MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y) ARGAN OIL (UNII: 4V59G5UW9X) HYALURONATE SODIUM (UNII: YSE9PPT4TH) BABASSU OIL (UNII: 8QSB4M5477) PEG-100 STEARATE (UNII: YD01N1999R) POLYSORBATE 60 (UNII: CAL22UVI4M) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) IRIS DOMESTICA ROOT (UNII: T2MU9QFA87) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) OCTANEDIOL (UNII: 806K32R50Z) STEARIC ACID (UNII: 4ELV7Z65AP) TEA TREE OIL (UNII: VIF565UC2G) TROLAMINE (UNII: 9O3K93S3TK) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) ALLANTOIN (UNII: 344S277G0Z) DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) ALCOHOL (UNII: 3K9958V90M) PHELLODENDRON AMURENSE BARK (UNII: PBG27B754G) COPTIS CHINENSIS ROOT (UNII: CXS4LJR7EL) ALOE VERA LEAF (UNII: ZY81Z83H0X) LUFFA AEGYPTIACA FRUIT (UNII: QKL9NEO1F9) CITRUS MAXIMA SEED (UNII: 083X55C543) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CENTELLA ASIATICA (UNII: 7M867G6T1U) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) POLYGALIC ACID (UNII: XCC6WEA55L) TOCOPHEROL (UNII: R0ZB2556P8) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) ADENOSINE (UNII: K72T3FS567) CERAMIDE NP (UNII: 4370DF050B) EDETATE DISODIUM (UNII: 7FLD91C86K) GREEN TEA LEAF (UNII: W2ZU1RY8B0) REYNOUTRIA JAPONICA ROOT (UNII: 7TRV45YZF7) SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S) ROSEMARY (UNII: IJ67X351P9) PEG-10 RAPESEED STEROL (UNII: 258O76T85M) HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP) CITRUS BERGAMIA LEAF (UNII: ZGS96VDV4T) LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M) ROSA CENTIFOLIA FLOWER (UNII: CS4TE8FF7O) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) CALCIUM PANTOTHENATE (UNII: 568ET80C3D) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73058-001-02 1 in 1 PACKAGE 04/18/2019 1 NDC:73058-001-01 15 g in 1 CONTAINER; 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 04/18/2019 Labeler - HELLO SKIN Co.,Ltd. (694804812) Registrant - HELLO SKIN Co.,Ltd. (694804812) Establishment Name Address ID/FEI Business Operations MICELL KOREA LAB CO., LTD 689851542 manufacture(73058-001)
