LE-BLEN FGF SERUM- glycerin, sh-polypeptide-11, sodium hyaluronate emulsion

Le-Blen FGF Serum by

Drug Labeling and Warnings

Le-Blen FGF Serum by is a Otc medication manufactured, distributed, or labeled by LeBlen Beauty Inc., Le-Blen Beauty, Inc., COSMETIC LAB, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

GLYCERIN (25%) --------------------------------------------------------------------------------------- Skin protectant

SH-POLYPEPTIDE-11 (0.95%) ---------------------------------------------------------------------- Skin protectant

SODIUM HYALURONATE (0.7%) ------------------------------------------------------------------ Skin protectant

Purpose

Skin protectant

Uses

Skin Care after laser treatments. Helps to restore aging signs of the skin. Wrinkle, dark spot, sagging skin and scar care

Warnings

For external use only

Do not use when skin is red, inflamed, irritated, or painful

When using this product

do not apply on other parts of the body

do not use on damaged or broken skin

avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water

do not apply directly to wound or open cut

Stop use and ask a doctor if

Rash or irritation on skin develops and lasts

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

Apply 2 or 3 drops after cleansing. Massage gently until it is absorbed.

Inactive Ingredients

Water(Aqua), Betaine, Xanthan gum, Phenoxyethanol, Polysorbate 20, Ethylhexylglycerin, Saccharomyces Lysate Extract, Superoxide Dismutase, Glucosamine HCL, Niacinamide, Algae Extract, Lavandula Augustifolia (Lavender) Oil

Le-Blen FGF Serum

INGREDIENTS AND APPEARANCE

LE-BLEN FGF SERUM 
glycerin, sh-polypeptide-11, sodium hyaluronate emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72271-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	14.18 g  in 56.7 g
FIBROBLAST GROWTH FACTOR-1 (UNII: G53298VN9Y) (FIBROBLAST GROWTH FACTOR-1 - UNII:G53298VN9Y)	FIBROBLAST GROWTH FACTOR-1	0.54 g  in 56.7 g
HYALURONATE SODIUM (UNII: YSE9PPT4TH) (HYALURONIC ACID - UNII:S270N0TRQY)	HYALURONATE SODIUM	0.4 g  in 56.7 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72271-101-01	56.7 g in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	04/24/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/24/2018

Labeler - LeBlen Beauty Inc. (091531100)

Registrant - LeBlen Beauty Inc. (091531100)

Establishment
Name	Address	ID/FEI	Business Operations
Le-Blen Beauty, Inc.		091531100	label(72271-101)

Establishment
Name	Address	ID/FEI	Business Operations
COSMETIC LAB, INC.		196409143	manufacture(72271-101)