SECRETIPSS SCALP HAIR ESSENTIAL TONIC PLUS HAIR REGROWTH TREATMENT WITH NATURAL INGREDIENTS AND VITAMIN COMPLEX- allantoin solution 
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: Allantoin 0.60%

INACTIVE INGREDIENT

Inactive Ingredients: Purified Water, Alcohol, Tocopheryl Acetate, Polysorbate 80, Salicylic Acid, Nicotinamide, Methylparaben, Panthenol, Monoethanolamine, Artemisia Princeps Extract, Glycyrrhiza Uralensis (Licorice) Root Extract, Panax Ginseng Root Extract

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

Indications and Usage: Shake the Secretipss Hair Essential Tonic Plus vigorously, and spray 8 to 10 times onto the parts showing hair loss and massage with fingertips for 5 minutes until the product is absorbed into the scalp and hair.

DOSAGE & ADMINISTRATION

Dosage and Administration: Take an adequate amount of this product.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

SECRETIPSS SCALP HAIR ESSENTIAL TONIC PLUS  HAIR REGROWTH TREATMENT WITH NATURAL INGREDIENTS AND VITAMIN COMPLEX
allantoin solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69684-210
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) Allantoin0.48 mg  in 80 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Alcohol (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69684-210-0180 mL in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34702/01/2015
Labeler - SECRETIPSS CO., LTD. (689275071)
Registrant - SECRETIPSS CO., LTD. (689275071)
Establishment
NameAddressID/FEIBusiness Operations
SECRETIPSS CO., LTD.689275071manufacture(69684-210)

Revised: 3/2015
Document Id: 2a17500f-f05d-4c67-addc-09b1e2082c6e
Set id: cdf0c7bf-f3bb-461e-9502-6b7411600bdf
Version: 1
Effective Time: 20150326
 
SECRETIPSS CO., LTD.