Label: SPAI-SONS PROLAC-VIT- biotin liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 66854-007-01, 66854-007-02 - Packager: SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Drug Label Information
Updated August 5, 2012
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- Official Label (Printer Friendly)
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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
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
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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
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INGREDIENTS AND APPEARANCE
SPAI-SONS PROLAC-VIT
biotin liquidProduct 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)