RENOVATING REGENERATING SERUM- glycerin cream

Renovating Regenerating Serum by

Drug Labeling and Warnings

Renovating Regenerating Serum by is a Otc medication manufactured, distributed, or labeled by Casmara Cosmetics, SA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WARNINGS

For external use only.

Do not use on damaged or broken skin.

When using this product keep our of the eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

Keep out of reach of children.

Whhen using this product do not get into eyes.

Children under 6 months: as a doctor.

ASK DOCTOR

Stop use and ask a doctor if rash occurs

Children under 6 months: ask a doctor

KEEP OUT OF REACH OF CHILDREN

. keep out of reach of children

Questions or Comments?

Questions or comments? + 34 961 501 099 M-F 9:00 am to 5:00 pm

OTHER SAFETY INFORMATION

. keep the product in a cool and dry place

Directions

. apply every day gently onto clean face and neck

. can be used in the morning and/or night

DOSAGE & ADMINISTRATION

. apply every day gently onto clean dace and neck

. can be used in the morning and/or night

Uses

. helps to prevent dehydration of the skin.

. helps maintain the hydrolipidic layer of the skin

INACTIVE INGREDIENT

water, propylene glycol, horse chestnut extract, PEG-25 castor oil, triethanolamine, phenoxyethanol, alcohol, PVM/MA Decadiene crospolymer, chestnut seed extract, glycolic acid, fragrance, lactic acid, polysorbate 20, tocopherol, ethylhexylglycerin, tetrasodium glutamate diacetate, caprylyl glycol, potassium thiocyanate, retinyl palmitate, inositol, calcium pantothenate, linoleic acid, lactoferrin, lactoperoxidase, disodium phosphate, biotin, acetyl hexapeptide-8, glucose pentaacetate, glucose oxidase, potassium phosphate

PURPOSE

. helps to prevent dehydration of the skin

. helps maintain the hydrolipidic layer of the skin

Active Ingredients

Glycerin 0.25%........................... Skin Protectant

PRINCIPAL DISPLAY PANEL

Renovating

Regenerating Serum

Skin Protectant

Moisturizing

RGnerin Enzyme

Facial Collection

INGREDIENTS AND APPEARANCE

RENOVATING REGENERATING SERUM 
glycerin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 20151-068
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	0.25 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
POLYOXYL 35 CASTOR OIL (UNII: 6D4M1DAL6O)	1.875 mg  in 1 mL
BUTYL ESTER OF METHYL VINYL ETHER-MALEIC ANHYDRIDE COPOLYMER (125 KD) (UNII: 389H2R62BD)	0.8 mg  in 1 mL
HORSE CHESTNUT (UNII: 3C18L6RJAZ)	0.3 mg  in 1 mL
POLYSORBATE 20 (UNII: 7T1F30V5YH)	0.15 mg  in 1 mL
LINOLEIC ACID (UNII: 9KJL21T0QJ)	0.027 mg  in 1 mL
LACTOPEROXIDASE BOVINE (UNII: 01UIN5OC49)	0.015 mg  in 1 mL
BIOTIN (UNII: 6SO6U10H04)	0.005 mg  in 1 mL
CALCIUM PANTOTHENATE, (-)- (UNII: 6IY177DF2V)	0.027 mg  in 1 mL
POTASSIUM THIOCYANATE (UNII: TM7213864A)	0.037 mg  in 1 mL
LACTOFERRIN, BOVINE (UNII: KG21X1090A)	0.025 mg  in 1 mL
GLUCOSE PENTAACETATE (UNII: 3040885R4N)	0.0035 mg  in 1 mL
GLUCOSE OXIDASE (UNII: 0T8392U5N1)	0.001 mg  in 1 mL
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)	0.027 mg  in 1 mL
SPANISH CHESTNUT (UNII: 2MT5XMR2YW)	1.875 mg  in 1 mL
GLYCOLIC ACID (UNII: 0WT12SX38S)	0.21 mg  in 1 mL
CAPRYLYL GLYCOL (UNII: 00YIU5438U)	0.05 mg  in 1 mL
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)	0.106 mg  in 1 mL
WATER (UNII: 059QF0KO0R)	72.75 mg  in 1 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T)	0.915 mg  in 1 mL
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)	0.094 mg  in 1 mL
TOCOPHEROL (UNII: R0ZB2556P8)	0.15 mg  in 1 mL
PERFLUNAFENE (UNII: 54A06VV62N)	0.2 mg  in 1 mL
POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51)	0.001 mg  in 1 mL
TROLAMINE (UNII: 9O3K93S3TK)	1 mg  in 1 mL
DIPROPYLENE GLYCOL (UNII: E107L85C40)	18 mg  in 1 mL
SODIUM PHOSPHATE (UNII: SE337SVY37)	0.0115 mg  in 1 mL
INOSITOL (UNII: 4L6452S749)	0.0275 mg  in 1 mL
ALCOHOL (UNII: 3K9958V90M)	0.875 mg  in 1 mL
ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)	0.005 mg  in 1 mL
LACTIC ACID (UNII: 33X04XA5AT)	0.18 mg  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 20151-068-02	1 in 1 BOTTLE, DISPENSING	05/13/2016
1	NDC: 20151-068-01	50 mL in 1 BOTTLE, DISPENSING; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	05/13/2016

Labeler - Casmara Cosmetics, SA (464973544)

Registrant - Casmara Cosmetics, SA (464973544)

Establishment
Name	Address	ID/FEI	Business Operations
Casmara Cosmetics, SA		464973544	manufacture(20151-068)