Label: MAETRIA MIRACLE RECIPE PREMIUMSHAMPOO- salicylic acid shampoo

  • 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 October 13, 2022

If you are a consumer or patient please visit this version.

  • Active ingredients

    Salicylic Acid 0.2%

  • Purpose

    Salicylic Acid 0.2% ……………….. Anti Dandruff

  • Uses

    Hair loss symptom relief shampoo cleanses the scalp of the hair and helps the healthy hair by supplying nutrients as the main ingredient

  • Warnings

    · Stop use and consult a specialist if there are any abnormal symptoms or side effects such as red spots, swelling or itching, due to direct sunlight when using or after using the product.
    · Do not use in areas with open wounds. · Keep out of reach of children.
    · When using the product, wash the eye immediately if it gets into the eye.
    · Do not leave the product unwashed, as it may cause hair loss or bleaching if it is not rinsed with water.
    · Keep it away from direct sunlight.

  • Warnings

    When using the product, wash the eye immediately if it gets into the eye.

  • Warnings

    Stop use and consult a specialist if there are any abnormal symptoms or side effects such as red spots, swelling or itching, due to direct sunlight when using or after using the product.

  • Warnings

    Keep out of reach of children.

  • Warnings

    Do not use in areas with open wounds.

  • Directions

    After fully wetting hair with water, apply an appropriate amount on hair and scalp. Fully lather and wash with lukewarm water.

  • Inactive ingredients

    Water, Sodium C14-16 Olefin Sulfonate, Propanediol, Coco-Betaine, PEG-120 Methyl Glucose Dioleate, Glycerin, Lycium Chinense Extract, Malus Domestica Fruit Cell Culture Extract, Vitis Vinifera (Grape) Fruit Cell Extract, Sodium Chloride, Caprylyl Glycol, Ethylhexylglycerin, Panthenol, Polyquaternium-10, Pentylene Glycol, Niacinamide, Rubus Idaeus (Raspberry) Fruit Extract, Citric Acid, Biotin,
    1,2-Hexanediol, Ecklonia Cava Extract, Menthol, Thuja Occidentalis Leaf Extract, Butylene Glycol, Disodium EDTA, Allantoin, Xanthan Gum, Sparassis Crispa Extract, Sophora Flavescens Root Extract, Capsicum Annuum Fruit Extract, Lycium Chinense Fruit Extract, Prunella Vulgaris Extract, Morinda Citrifolia Extract, Camellia Sinensis Leaf Extract, Perilla Frutescens Leaf Extract, Vitex Trifolia Fruit Extract, Houttuynia Cordata Extract, Polygala Tenuifolia Root Extract, Ginkgo Biloba Leaf Extract, Eclipta Prostrata Extract, Commiphora Myrrha Oil, Hydroxyacetophenone, Angelica Gigas Root Extract, Angelica Dahurica Root Extract, Pinus Palustris Leaf Extract, Rubus Coreanus Fruit Extract, Morus Alba Root Extract, Lithospermum Erythrorhizon Root Extract, Polygonum Multiflorum Root Extract, Paeonia Suffruticosa Root Extract, Pisum Sativum (Pea) Peptide, Cornus Officinalis Fruit Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Rehmannia Glutinosa Root Extract, Phellinus Linteus Extract, Pueraria Lobata Root Extract, Scutellaria Baicalensis Root Extract, Caprylhydroxamic Acid, Swiftlet Nest Extract, Genistein, Resveratrol, Acetyl Tetrapeptide-3, Alanine/Histidine/Lysine Polypeptide Copper HCl, Fragrance

  • Display panel

    J1010_Label

  • INGREDIENTS AND APPEARANCE
    MAETRIA MIRACLE RECIPE PREMIUMSHAMPOO 
    salicylic acid shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82934-401
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
    LYCIUM CHINENSE FRUIT (UNII: TG711Q7A1Q)  
    PRUNELLA VULGARIS (UNII: Y45L13XZ2U)  
    MORINDA CITRIFOLIA LEAF (UNII: 7UOL7P5FF5)  
    ANGELICA DAHURICA ROOT (UNII: 1V63N2S972)  
    LITHOSPERMUM ERYTHRORHIZON ROOT (UNII: 9I70D8O47I)  
    PAEONIA X SUFFRUTICOSA ROOT (UNII: 7M7E9A2C8J)  
    CORNUS OFFICINALIS FRUIT (UNII: 23NL8NQ187)  
    PEA (UNII: W4X7H8GYFM)  
    ACENEURAMIC ACID (UNII: GZP2782OP0)  
    WINE GRAPE (UNII: 3GOV20705G)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    PUERARIA MONTANA VAR. LOBATA ROOT (UNII: PET93F4I3C)  
    ALANINE (UNII: OF5P57N2ZX)  
    WATER (UNII: 059QF0KO0R)  
    PHELLINUS LINTEUS WHOLE (UNII: YVO92B1UCA)  
    HOUTTUYNIA CORDATA FLOWERING TOP (UNII: RH041UUZ22)  
    ECLIPTA PROSTRATA LEAF (UNII: H86R96580E)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    GINKGO (UNII: 19FUJ2C58T)  
    MYRRH OIL (UNII: H74221J5J4)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    RASPBERRY (UNII: 4N14V5R27W)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    BIOTIN (UNII: 6SO6U10H04)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    ECKLONIA CAVA (UNII: UXX2N5V39P)  
    MENTHOL (UNII: L7T10EIP3A)  
    THUJA OCCIDENTALIS LEAF (UNII: 0T0DQN8786)  
    SPARASSIS CRISPA FRUITING BODY (UNII: BOO3RTP9PX)  
    PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  
    VITEX TRIFOLIA FRUIT (UNII: Q04E1F5351)  
    POLYGALA TENUIFOLIA ROOT (UNII: 5S7W573MTU)  
    ANGELICA GIGAS ROOT (UNII: 32766B2FHX)  
    SODIUM SULFATE (UNII: 0YPR65R21J)  
    TETRADECENE (UNII: FW23481S7S)  
    HEXADECENE (MIXED ISOMERS) (UNII: 38H8547VP0)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    COCO-BETAINE (UNII: 03DH2IZ3FY)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALLANTOIN (UNII: 344S277G0Z)  
    PINUS PALUSTRIS LEAF (UNII: OT6R5143A1)  
    RUBUS COREANUS FRUIT (UNII: 18VM55XVF7)  
    MORUS ALBA ROOT (UNII: CST1G9BZGD)  
    REYNOUTRIA MULTIFLORA ROOT (UNII: AUZ3VD75MC)  
    LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)  
    REHMANNIA GLUTINOSA ROOT (UNII: 1BEM3U6LQQ)  
    RESVERATROL (UNII: Q369O8926L)  
    FRAGRANCE FLORAL ORC0902236 (UNII: R66Z4YW3X0)  
    ACETYL TETRAPEPTIDE-3 (UNII: D1HW9N9QBX)  
    SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)  
    PAPRIKA (UNII: X72Z47861V)  
    GENISTEIN (UNII: DH2M523P0H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82934-401-011 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/13/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM03210/13/2022
    Labeler - J 1010 Co., Ltd. (695562861)
    Registrant - J 1010 Co., Ltd. (695562861)
    Establishment
    NameAddressID/FEIBusiness Operations
    J 1010 Co., Ltd.695562861manufacture(82934-401)