BDR RE-CONSTRUCT ENRICHED NOURISHING FORMULA- niacinamide cream

bdr Re-construct enriched nourishing formula by

Drug Labeling and Warnings

bdr Re-construct enriched nourishing formula by is a Otc medication manufactured, distributed, or labeled by Hanaim International Llc, Goldeneye Permanent System Gmbh Germany. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Niacinamide (0.04%)

Purpose

Skin protectant

Keep out of reach of children

Do not swallow. In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Warnings

For external use only
Do not use when Your skin is red, inflamed, irritated or painful
When using this product
 Do not apply on other parts of the body
 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 doctor if rash or irritation on skin develops and lasts.
Keep out of reach of children
 Do not swallow. In case of accidental ingestion, seek professional assistance.
Store at room temperature

Uses

Moisturizes skin and keeps skin smooth and soft for very dry or sensitive skin.

Directions

Apply morning and evening after cleansing on face and neck daily.

Inactive Ingredients

AQUA (WATER), CAPRYLIC/CAPRIC TRIGLYCERIDE, GLYCERIN, ISODECYL NEOPENTANOATE, BORON NITRIDE, POLYGLYCERYL-3- POLYRICINOLEATE, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, OCTYLDODECANOL, C12-15 ALKYL BENZOATE, PERSEA GRATISSIMA (AVOCADO) OIL, HYDROGENATED CASTOR OIL, ARGANIA SPINOSA OIL (ARGANIA SPINOSA KERNEL OIL) [ARGANOIL], THEOBROMA GRANDIFLORUM SEED BUTIER ( CUPUACU BUTIER), TRITICUM VULGARE (WHEAT) GERM OIL, GLYCERYL OLEATE, MAGNESIUM SULFATE, SODIUM LACTATE, SODIUM PCA, PHENOXYETHANOL, MAGNESIUM STEARATE, TRIBEHENIN, ECHIUM PLANTAGINEUM SEED OIL, TOCOPHEROL , GLYCINE SOJA (SOYBEAN) OIL, GLYCINE SOJA (SOYBEAN) STEROL, AROMA/FLAVOR, GLYCERYL CAPRYLATE, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL UNSAPONIFIABLES, ETHYL FERULATE, SORBITAN LAURATE, POLYGLYCERYL-5 TRIOLEATE, BENZOIC ACID, LUPINUS ALBUS SEED EXTRACT, TRISTEARIN, CERAMIDE NG, DEHYDROACETIC ACID, CETEARYL ALCOHOL,FRUCTOSE, CARDIOSPERMUM HALICACABUM FLOWER/LEAFNINE EXTRACT, GLYCINE, INOSITOL, LACTIC ACID, NIACINAMI DE, UREA, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT, ACETYLATED GLYCOL STEARATE, SODIUM BENZOATE, ASCORBYL PALMITATE, HYDROGENATED PALM GLYCERIDES CITRATE, DISODIUM URIDINE PHOSPHATE, PALMITOYL HEXAPEPTIDE-12, PALMITOYL TRIPEPTIDE-1, PALMITOYL TETRAPEPTI DE-7

bdr Re-construct enriched nourishing formula

INGREDIENTS AND APPEARANCE

BDR RE-CONSTRUCT ENRICHED NOURISHING FORMULA 
niacinamide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71056-109
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	0.02 g  in 55 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCERIN (UNII: PDC6A3C0OX)
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)
BORON NITRIDE (UNII: 2U4T60A6YD)
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)
SUNFLOWER OIL (UNII: 3W1JG795YI)
OCTYLDODECANOL (UNII: 461N1O614Y)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
AVOCADO OIL (UNII: 6VNO72PFC1)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
ARGAN OIL (UNII: 4V59G5UW9X)
THEOBROMA GRANDIFLORUM SEED BUTTER (UNII: I711F13FXM)
WHEAT GERM OIL (UNII: 14C97E680P)
GLYCERYL OLEATE (UNII: 4PC054V79P)
SODIUM LACTATE (UNII: TU7HW0W0QT)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
SOY STEROL (UNII: PL360EPO9J)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
ETHYL FERULATE (UNII: 5B8915UELW)
SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)
BENZOIC ACID (UNII: 8SKN0B0MIM)
LUPINUS ALBUS SEED (UNII: 24GB753W3B)
TRISTEARIN (UNII: P6OCJ2551R)
CERAMIDE NG (UNII: C04977SRJ5)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
FRUCTOSE (UNII: 6YSS42VSEV)
CARDIOSPERMUM HALICACABUM FLOWERING TOP (UNII: MZP2508BRR)
GLYCINE (UNII: TE7660XO1C)
INOSITOL (UNII: 4L6452S749)
LACTIC ACID (UNII: 33X04XA5AT)
UREA (UNII: 8W8T17847W)
ROSEMARY (UNII: IJ67X351P9)
ACETYLATED GLYCOL STEARATE (UNII: K71M6R9N7E)
SODIUM BENZOATE (UNII: OJ245FE5EU)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)
URIDINE MONOPHOSPHATE DISODIUM (UNII: KD8E20071T)
PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C)
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71056-109-02	1 in 1 PACKAGE	11/18/2016
1	NDC: 71056-109-01	55 mL in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		11/18/2016

Labeler - Hanaim International Llc (070319425)

Registrant - Hanaim International Llc (070319425)

Establishment
Name	Address	ID/FEI	Business Operations
Hanaim International Llc		070319425	relabel(71056-109)

Establishment
Name	Address	ID/FEI	Business Operations
Goldeneye Permanent System Gmbh Germany		329178144	manufacture(71056-109)