SPAI-SONS PROLAC-VIT- biotin liquid 
SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS

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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SPAI-SONS PROLAC-VIT

Biotin is a major component of the formulation acts to strengthen the hair follicle and prevents hair loss as well. It is nutrient for the hair root oxygenate the hair turn slowing the loss. Provides resilience and resistence to hair. Addition of biotin are other ingredient such as Asian Ginseng, Arginine, Zinc Gluconate, Niacinamide, Ornitine HCl, and Citrulline which help strengthen the hair follicle and produce a synergistic action on it.

Prolac-vit is a well balanced formula that helps the function and nutrition of hair root, resulting in abundant hair and neutralizing alopecia caused by lack and certain components, mistreatment or toxic agents.

This product must be keep out reach of children

This product is for topical application directly on the hair follicle.

Avoid contact with eyes, if they do wash with water. If swallowed contact a physician immediately

Recommended use: thin or fragile, ill-treated hair, malnourished scalp or hair roots, Alopecia, hair loss due to cycle change.

Directions: must be applied directly to the scalp and then massage very gently until the product is absorbed

This is a liquid prepared with the technology needed to provide the hair follicle absorption of the active ingredients, plus inactive ingredients contribute to the regeneration of the hair fiber by providing a strengthening therefore. No adverse effects were seen with the use of this product as inactive ingredients do not cause skin hypersensivity.

IMAGE OF CARTON LABEL IMAGE OF CARTON LABEL

SPAI-SONS  PROLAC-VIT
biotin liquid
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:66854-007
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN0.01 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
ASIAN GINSENG (UNII: CUQ3A77YXI)  
ARGININE (UNII: 94ZLA3W45F)  
N-ACETYL-TYROSINE (UNII: DA8G610ZO5)  
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)  
ASPARTIC ACID (UNII: 30KYC7MIAI)  
HYDROXYPROLINE (UNII: RMB44WO89X)  
THREONINE (UNII: 2ZD004190S)  
SERINE (UNII: 452VLY9402)  
GLUTAMIC ACID (UNII: 3KX376GY7L)  
PROLINE (UNII: 9DLQ4CIU6V)  
GLYCINE (UNII: TE7660XO1C)  
ALANINE (UNII: OF5P57N2ZX)  
VALINE (UNII: HG18B9YRS7)  
METHIONINE (UNII: AE28F7PNPL)  
ISOLEUCINE (UNII: 04Y7590D77)  
LEUCINE (UNII: GMW67QNF9C)  
TYROSINE (UNII: 42HK56048U)  
PHENYLALANINE (UNII: 47E5O17Y3R)  
HYDROXYLYSINE (UNII: 2GQB349IUB)  
ORNITHINE (UNII: E524N2IXA3)  
LYSINE (UNII: K3Z4F929H6)  
HISTIDINE (UNII: 4QD397987E)  
ARGININE (UNII: 94ZLA3W45F)  
TRYPTOPHAN (UNII: 8DUH1N11BX)  
CYSTINE (UNII: 48TCX9A1VT)  
POLYQUATERNIUM-11 (1000000 MW) (UNII: 0B44BS5IJS)  
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)  
CALCIUM PANTOTHENATE (UNII: 568ET80C3D)  
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
NIACINAMIDE (UNII: 25X51I8RD4)  
ORNITHINE HYDROCHLORIDE (UNII: HBK84K66XH)  
CITRULLINE (UNII: 29VT07BGDA)  
GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
AMNIOTIC FLUID (BOVINE) (UNII: P06X62O7E9)  
HYDROLYZED PLACENTAL PROTEIN (BOVINE) (UNII: KR5CS6RBH9)  
WHEAT GERM (UNII: YR3G369F5A)  
POLYQUATERNIUM-39 (35/35/30 ACRYLIC ACID/ACRYLAMIDE/DADMAC; 1500000 MW) (UNII: EOD3UE785A)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
CARBOMER INTERPOLYMER TYPE A (55000 MPA.S) (UNII: 59TL3WG5CO)  
TROLAMINE (UNII: 9O3K93S3TK)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SULFUR (UNII: 70FD1KFU70)  
PANTHENOL (UNII: WV9CM0O67Z)  
ALLANTOIN (UNII: 344S277G0Z)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
MENTHOL (UNII: L7T10EIP3A)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Product Characteristics
ColorblueScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66854-007-0170 mL in 1 BOTTLE
2NDC:66854-007-0210 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other08/06/2012
Labeler - SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS (880172184)
Establishment
NameAddressID/FEIBusiness Operations
SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS880172184manufacture(66854-007) , analysis(66854-007) , label(66854-007) , pack(66854-007)

Revised: 8/2012
Document Id: 314f1ebc-353d-413e-beff-ddf3336e051a
Set id: 4c294bea-5a61-4756-af3c-17ed30f2c0d8
Version: 1
Effective Time: 20120805
 
SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS