HAIRFILL SCALP HAIR ESSENTIAL- dimethicone shampoo 
SECRETIPSS CO., LTD.

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.

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ACTIVE INGREDIENT

Active Ingredient: Dimethicone 1%

INACTIVE INGREDIENT

Inactive Ingredients: Water, Ammonium Laureth Sulfate, Ammonium Lauryl Sulfate, Cocamidopropyl Betaine, Zinc Pyrithione, Sodium Citrate, Butylene Glycol, Panthenol, Cocamide MEA, Carbomer, Sodium Chloride, Polyquaternium-10, Citric Acid, Niacinamide, Zinc Chloride, Simmondsia Chinensis (Jojoba) Seed Oil, Methylparaben, Laureth-4, Biotin, Disodium EDTA, Laureth-23, Sodium Benzoate, Glycyrrhiza Glabra (Licorice) Root Extract, Artemisia Vulgaris Extract, Panax Ginseng Root Extract, Fragrance, Methylchloroisothiazolinone, Methylisothiazolinone, Phenoxyethanol

PURPOSE

Purpose: Skin Protectant

WARNINGS

Warnings: 1. It is not used in the following cases. Skin and scalp there is a skin wound or mucous membrane, such as eczema, damaged 2. People such as the following, consult your doctor and pharmacist before using this medicine People who have (such as dermatitis rash, redness, itching, with lacquer, etc.) allergy symptoms caused by cosmetics and medicine came out 3. Be discontinued immediately the use of this drug in the following cases, consult your doctor or pharmacist, at the time of consultation, as far as possible, be in possession of this package insert 1) If rash, erythema, itching, swelling, and the like are displayed 2) If severe pain and itching as displayed 4. Notes when using this drug other 1) To be used only for the outside. The (non-oral) 2) Be careful so that it does not get in your eyes, flush with clean water when it gets if, it is recommended that you consult with an ophthalmologist if symptoms are severe. 3) Be careful when you are repeating the same site, because it may scalp becomes rough degreasing etc. (degreasing).

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of babies and children

INDICATIONS & USAGE

Direction & Dosage: After throughly wetting the hair and scalp with lukewarm water, evenly massage the scalp with 3-5 ml of the product. Leave it on for 3 minutes and then wash off.

DOSAGE & ADMINISTRATION

Direction & Dosage: After throughly wetting the hair and scalp with lukewarm water, evenly massage the scalp with 3-5 ml of the product. Leave it on for 3 minutes and then wash off.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of bottle

HAIRFILL SCALP HAIR ESSENTIAL 
dimethicone shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69684-320
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone2.4 mg  in 240 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PYRITHIONE ZINC (UNII: R953O2RHZ5)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69684-320-01240 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/01/2015
Labeler - SECRETIPSS CO., LTD. (689275071)
Registrant - SECRETIPSS CO., LTD. (689275071)
Establishment
NameAddressID/FEIBusiness Operations
SECRETIPSS CO., LTD.689275071manufacture(69684-320)

Revised: 6/2015
Document Id: cebef84a-13c9-4c2c-b983-96e6af40a333
Set id: 9bf32587-5547-4450-8d5e-c2c8db2cca0a
Version: 2
Effective Time: 20150609
 
SECRETIPSS CO., LTD.