SPAI-SONS PROCAPELL- biotin liquid

SPAI-SONS by

Drug Labeling and Warnings

SPAI-SONS 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 resistance to hair. Addition of biotin are other ingredient such as apigenin, biotinoyl tripeptide-1 and ginkgo extract which help strengthen the hair follicle and produce a synergistic action on it.

PURPOSE

A biotechnological product that accelerates the cellular biodynamics to slow down hair loss.

1. Delays the aging process of the capillary follicle and accelerates its growth

2. Strengthens hair stem and stimulates hair growth

3. Repairs and protects the structure of the hair follicle, prolonging hair life.

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: slow  down hair loss; accelerates growth and increments hair recovery.

Directions: apply every 12 hours on scalp and acitivate tapping softly with fingertips.

INACTIVE INGREDIENT

This is a liquid product 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 THE CARTON LABEL

INGREDIENTS AND APPEARANCE

SPAI-SONS  PROCAPELL
biotin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66854-011
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
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)
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)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
HYDROLYZED PLACENTAL PROTEIN (BOVINE) (UNII: KR5CS6RBH9)
ROSMARINUS OFFICINALIS FLOWERING TOP (UNII: 8JM482TI79)
MALVA SYLVESTRIS FLOWERING TOP (UNII: X1U1U0N90J)
PANTHENOL (UNII: WV9CM0O67Z)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
MENTHOL (UNII: L7T10EIP3A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66854-011-01	70 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