BIONA-VIT CONTROLS AND PREVENTS HAIR LOSS- biotin liquid

BIONA-VIT by

Drug Labeling and Warnings

BIONA-VIT by is a Otc 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 and helps oxygenate the hair turn slowing the loss. Provides resilience and resistence to hair.

PURPOSE

- Non invasive and painless treatment

- Keeps hair strong, rich and silky

- Nourishes the hair and scalp

KEEP OUT OF REACH OF CHILDREN

This product must be keep out reach of the children

INDICATIONS & USAGE

This product can be applied to any person, is for topical application

WARNINGS

This product is for topical application, if this product to contact with eyes rinse immediately with water and consult your doctor.

DOSAGE & ADMINISTRATION

- Apply amount of the hair follicle and massage until absorbed continous product. Use every 12 hours for the fast and sustained effect.

- Suitable for children, adolescents, adults and seniors.

INACTIVE INGREDIENT

This product is prepared in a non-greasy gel base, as well as biotin are other ingredients such apigenin, biotinoyl tripeptide-1 and ginkgo extract which help strengthen the hair follicle and produces a synergistic action on it.

This product do not produces adverse effects in the scalp

PRINCIPAL DISPLAY PANEL

IMAGE OF THE LABEL

INGREDIENTS AND APPEARANCE

BIONA-VIT  CONTROLS AND PREVENTS HAIR LOSS
biotin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66854-010
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
APIGENIN (UNII: 7V515PI7F6)
OLEANOLIC ACID (UNII: 6SMK8R7TGJ)
BIOTINOYL TRIPEPTIDE-1 (UNII: O6380721VA)
GINKGO (UNII: 19FUJ2C58T)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
HYDROLYSED BOVINE COLLAGEN (ENZYMATIC; 2000-5000 MW) (UNII: 5WE8P977RQ)
HYDROLYZED PLACENTAL PROTEIN (BOVINE) (UNII: KR5CS6RBH9)
CARBOMER INTERPOLYMER TYPE A (55000 MPA.S) (UNII: 59TL3WG5CO)
TROLAMINE (UNII: 9O3K93S3TK)
DMDM HYDANTOIN (UNII: BYR0546TOW)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66854-010-02	20 in 1 BOX
1	NDC: 66854-010-01	17 mL in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/30/2012

Labeler - SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS (880172184)

Registrant - SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS (880172184)

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