Label: MOJELIM DR- pyrithione zinc shampoo
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Contains inactivated NDC Code(s)
NDC Code(s): 71194-010-01, 71194-010-02 - Packager: MOJELIM COSMEDI 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 February 27, 2017
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- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Inactive ingredients: Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Lauryl Sulfate, Alcohol Denat, Yeast, TEA-Lauryl Sulfate, trihydroxystearin, Polyquaternium-10, Tromethamin, Parfum, Glycerin, Cocamide MEA, Tetrasodium EDTA, Panthenol, Safflower Yellow, PEG-60 Hydrogenated Castor Oil, Niacinamide, Sodium Benzoate, Sophora Angustifolia Root Extract, Paeonia Albiflora Root Extract, Tocopheryl Acetate, Salicylic Acid, PVP, Sodium Chloride, Citric Acid, Panax Ginseng Root Extract, Thuja Occidentalis Leaf Extract, Morus Alba Bark Extract, Chrysanthemum Zawadskii Extract, Lycium Chinense Fruit Extract, Acorus Gramineus Root/Stem Extract, Xanthium Strumarium Fruit Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Mentha Arvensis Extract, Biotin, Glycine, Betaine, PCA, Camellia Sinensis Leaf Extract, Saccharomyces/Rice Bran Ferment, Glycine Soja (Soybean) Seed Extract, Hydrolyzed Silk, Hydrolyzed Keratin, Houttuynia Cordata Extract, Perilla Frutescens Leaf Extract, Ginkgo Biloba Leaf Extract, Panax Ginseng Root Extract, Chamaecyparis Obtusa Water, Cysteine, Camellia Japonica Seed Oil, Olea Europaea (Olive) Fruit Oil
- PURPOSE
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WARNINGS
Warnings: For external use only 1. Avoid using on the following area. Scalp and skin affected by eczema. 2. Be cautious in the following case. Anyone who suffered from allergies (dermatitis due to rash, flare, itchiness, and lacquer) by drug or cosmetic 3. Consult with the doctor or pharmacist after discontinuing the use in case of symptoms, such as rash, flare and itchiness, caused by the usage of the drug. 4. General caution 1) Avoid contact with eyes. In case of contact with eyes, promptly rinse with water. In case the symptom is severe, receive treatment by an ophthalmologist. 2) Use the drug only for external use and not for internal use. 5. Caution on storage 1) Avoid direct sunlight and store in a cool place if possible. 2) Do not put in other container to maintain its quality and prevent misuse. 3) Avoid the location exposed to open flame and keep out of reach of children.
- KEEP OUT OF REACH OF CHILDREN
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INDICATIONS & USAGE
Indications & Usage: ① Prevention efficacy of dandruff by keeping the hygiene of the scalp ② May have the efficacy on hair loss prevention as well as hair thickness improvement ③ Hypo-allergenic on scalp with 23 types of natural components ④ Containing beer yeast extracts with abundant vitamin and protein ⑤ Enhancement of luster and elasticity by nourishing the scalp and hair
- DOSAGE & ADMINISTRATION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MOJELIM DR
pyrithione zinc shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71194-010 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC 10.0 g in 500 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Sodium Laureth Sulfate (UNII: BPV390UAP0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71194-010-02 1 in 1 CARTON 02/01/2017 1 NDC:71194-010-01 500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 02/01/2017 Labeler - MOJELIM COSMEDI CO., LTD (689851474) Registrant - MOJELIM COSMEDI CO., LTD (689851474) Establishment Name Address ID/FEI Business Operations MOJELIM COSMEDI CO., LTD 689851474 relabel(71194-010) Establishment Name Address ID/FEI Business Operations Seoul cosmetics co.,ltd 688397660 manufacture(71194-010)