O SHA MPOO PREMIUM- glycerin shampoo 
Herbearth

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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ACTIVE INGREDIENT

Active Ingredient: Disodium Laureth Sulfosuccinate 30.0%, Cocamidopropyl Betaine 8.0%, Glycerin 2.5%

INACTIVE INGREDIENT

Inactive Ingredients: Water, Polyquaternium-10, Dimethicone, Panthenol, Menthol, Malt Extract, Sodium Hyaluronate, Sodium Benzoate, Rosmarinus Officinalis (Rosemary) Leaf Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Symphytum Officinale Leaf Extract, Urtica Dioica (Nettle) Extract, Tocopheryl Acetate, Sorbic Acid, Sophora Angustifolia Root Extract, Eclipta Prostrata Extract, Panax Ginseng Root Extract, Lycium Chinense Fruit Extract, Polygonum Multiflorum Root Extract, Disodium EDTA, Paeonia Albiflora Root Extract, Acorus Gramineus Root/Stem Extract, Thuja Orientalis Extract, Scutellaria Baicalensis Root Extract, Cnidium Officinale Root Extract, Citrus Unshiu Peel Extract, Chaenomeles Sinensis Fruit Extract, Methylisothiazolinone, Laminaria Japonica Extract, Rehmannia Chinensis Root Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Zingiber Officinale (Ginger) Root Extract, Perilla Frutescens Leaf Extract, Pinus Palustris Leaf Extract, Methylchloroisothiazolinone.

PURPOSE

Purpose : Shampoo (cleaning hair and scalp)

WARNINGS

Warnings: 1. Discontinue to use this production if the below symptoms occure in use : Damage on the skin or scalp such as mucosa, scar or eczema. 2. In case of having following symptoms, consult the medical specialist before use. In case of having allergy(like red rash, swollenness, itching, dermatitis) caused by drug or cosmetics. 3. Immediately stop using and consult the medical specialist for below cases. (Consult with this affixation, if possible.) (a)In case of having problems such as red rash, swollenness, itching stimulation during usage (b) In case of having pruritis or pain. 4. Others caution in usage. (a)External use only.(Internal use forbidden.) (b)Be careful not to get it into your eyes and in case you have to wash it immediately and consult the medical specialist if the symptom gets worse. (c)Be careful of overuse so that the scalp could not lose its oil and it gets roughen. 5. Caution in storage (a)Protect from light and heat. Store in the shade. (b)Keep out of reach of children. (c)Causing accident or degradation from keeping in the different containers from the oriinal container, keep in the designated container with airtight lid.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

INDICATIONS & USAGE

Indications and usage: 1. Better to wash in the evening to get rid of foreign substances on the scalp accumulated during the day. 2. A through wash is required. 3. Dry in a mild-warm air 4. Wash face and/or shave with bubbles left on hair for 1 to 2 minutes before washing out. 5. Do not use rinse products while using O shampoo 6. Taking half-bath with bubbles on the hair makes you feel fresh.

DOSAGE & ADMINISTRATION

Dosage and administration: Use an adequate amount of this product Suggested use is once a day.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of bottle

O SHA MPOO PREMIUM 
glycerin shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71043-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN7.5 g  in 300 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Dimethicone (UNII: 92RU3N3Y1O)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71043-010-01300 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/01/2016
Labeler - Herbearth (689059857)
Registrant - Herbearth (689059857)
Establishment
NameAddressID/FEIBusiness Operations
Herbearth689059857manufacture(71043-010)

Revised: 10/2016
Document Id: a15f1715-e109-4901-80c5-8b5189f5d17e
Set id: 0c8a9aea-fb27-4b7d-a12c-5de3c81c195b
Version: 1
Effective Time: 20161028
 
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