VERSION X SCALP TONIC- allantoin liquid 
CHRISTLTD

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 0.5%

INACTIVE INGREDIENT

Inactive ingredients:
Water,SD Alcohol 40-B,Butylene Glycol,Nonoxynol-12,Propylene Glycol,Panthenol,Fragrance,0.3H0.1ydrolyzed Soy Protein,DMDM Hydantoin,Menthol,Peg-60 Almond Glycerides,Hair Keratin, Amino Acids,Sodium Chondroitin Sulfate,3-Aminopropane Sulfonic Acid,Chlorphenesin, Xantham Gum,PG-Propyl Silanetriol,Hydrolyzed Wheat Protein,Ethyl Nicotinate,Benzophenone-4, Sodium PCA,Yellow 6 (CI 15985),Red 40 (CI 16035),Blue 1 (CI 42090),Sodium Chloride,Disodium EDTA,Alcohol,Cetyl Triethylmonium Dimethicone PEG-8phthalate,Ginkgo Biloba Leaf Extract,Swertia Japonica Extract,Laminaria Digitata Extract,Pelvetia Canaliculata Extract,Anacyclus Pyrethrum, Root Extract,Beta Vulgaris (Beet) Root Extract,Adiantum Pedatum Extract,Flower Extract, Eugenia Caryophyllus (Clove),Hedychium CoronariumRoot Extract,Arnica Montana Flower Extract, Urtica Dioica (Nettle) Extract,Rosmarinus Officinalis(Rosemary) Leaf Extract,Shell Extract,Juglans Nigra(Black Walnut),Salvia Officinalis (Sage) Leaf Extract, Hamamelis Virginiana,Quillaja Saponaria Bark Extract,Algae Extract,Phytantriol,Biotin,Niacin,Retinyl Palmitate, Tocopheryl Nicotinate

PURPOSE

Purpose: Skin Protectant

WARNINGS

CAUTION:
For external use only.
Avoid eye contact.
Keep out of reach children.
In case of accidental ingestion, seek professional attention immediately.
Some redness and iffitation of the scalp is nomal

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

INDICATIONS AND USAGE

DIRECTIONS
Apply directly to clean, towel-dried scalp.
Spray the stimulant to the affected and surrounding areas of the scalp once daily.
Gently massage the stimulant into the scalp for 10-20 seconds.
Do not wash or rinse hair for at least three hours. For best results continue use on a daily basis.

DOSAGE AND ADMINISTRATION

DIRECTIONS
Apply directly to clean, towel-dried scalp.
Spray the stimulant to the affected and surrounding areas of the scalp once daily.
Gently massage the stimulant into the scalp for 10-20 seconds.
Do not wash or rinse hair for at least three hours. For best results continue use on a daily basis.

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

Image of carton

VERSION X SCALP TONIC 
allantoin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58069-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) Allantoin0.625 mg  in 125 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Panthenol (UNII: WV9CM0O67Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58069-010-01125 mL in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34702/01/2013
Labeler - CHRISTLTD (557806035)
Registrant - CHRISTLTD (557806035)
Establishment
NameAddressID/FEIBusiness Operations
CHRISTLTD557806035manufacture(58069-010)

Revised: 5/2013
Document Id: 7b51f02c-9e36-4469-97ac-c6baec73b6fe
Set id: 3ff15154-bdb0-4082-aaf8-79c2564eca63
Version: 2
Effective Time: 20130521
 
CHRISTLTD