SPAI-SONS PROLAC-VIT- biotin liquid

SPAI-SONS by

Drug Labeling and Warnings

SPAI-SONS by is a Prescription medication manufactured, distributed, or labeled by SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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.

PURPOSE

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.

KEEP OUT OF REACH OF CHILDREN

This product must be keep out reach of children

INDICATIONS & USAGE

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

WARNINGS

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

DOSAGE & ADMINISTRATION

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

INACTIVE INGREDIENT

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.

PRINCIPAL DISPLAY PANEL

IMAGE OF CARTON LABEL

INGREDIENTS AND APPEARANCE

SPAI-SONS  PROLAC-VIT
biotin liquid

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 66854-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04)	BIOTIN	0.01 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	blue	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66854-007-01	70 mL in 1 BOTTLE
2	NDC: 66854-007-02	10 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/06/2012

Labeler - SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS (880172184)

Establishment
Name	Address	ID/FEI	Business Operations
SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS		880172184	manufacture(66854-007) , analysis(66854-007) , label(66854-007) , pack(66854-007)