BDR RE-FINE PORE MINIMIZING FLUID COMPLEX- panthenol lotion

bdr Re-fine pore minimizing fluid complex by

Drug Labeling and Warnings

bdr Re-fine pore minimizing fluid complex by is a Otc medication manufactured, distributed, or labeled by Goldeneye Permanent System Gmbh Germany, Hanaim International Llc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Panthenol (0.75%)

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

Helps to refine pores, reduce and soften wrinkles. Keep skin soft and smooth

Directions

Apply 1-2 dosage unit morning and evening, prior to usual care.

Inactive Ingredients

AQUA (WATER), ISODECYL NEOPENTANOATE, PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL, SUCROSE STEARATE, BETAINE, GLYCERIN, ALCOHOL, PANTHENOL, PHENOXYETHANOL, TOCOPHEROL, ALLANTOIN, HORDEUM VULGARE EXTRACT, GLYCOSPHINGOLIPIDS, SODIUM HYDROXIDE, PANTHENYL TRIACETATE, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, RETINYL PALMITATE, GLYCINE SOJA (SOYBEAN) OIL, PERSEA GRATISSIMA (AVOCADO) OIL, GLYCINE SOJA (SOYBEAN) STEROL, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, CARBOMER, SODIUM CARBOXYMETHYL BETAGLUCAN, XANTHAN GUM, PARFUM (FRAGRANCE), DEHYDROXANTHAN GUM, BENZOIC ACID, DEHYDROACETIC ACID, SODIUM HYALURONATE, CHLORELLA VULGARIS EXTRACT, CETEARYL ALCOHOL , PLANKTON EXTRACT, HYDROGENATED PALM GLYCERIDES CITRATE, ASCORBYL PALMITATE

bdr Re-fine pore minimizing fluid complex

INGREDIENTS AND APPEARANCE

BDR RE-FINE PORE MINIMIZING FLUID COMPLEX 
panthenol lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71056-110
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PANTHENOL (UNII: WV9CM0O67Z) (PANTHENOL - UNII:WV9CM0O67Z)	PANTHENOL	0.09 g  in 12 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)
ALMOND OIL (UNII: 66YXD4DKO9)
SUCROSE STEARATE (UNII: 274KW0O50M)
BETAINE (UNII: 3SCV180C9W)
GLYCERIN (UNII: PDC6A3C0OX)
ALCOHOL (UNII: 3K9958V90M)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TOCOPHEROL (UNII: R0ZB2556P8)
ALLANTOIN (UNII: 344S277G0Z)
HORDEUM VULGARE WHOLE (UNII: 8JBE478M5Q)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PANTHENOL TRIACETATE, (+)- (UNII: 1206E8961B)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
SOYBEAN OIL (UNII: 241ATL177A)
AVOCADO OIL (UNII: 6VNO72PFC1)
SOY STEROL (UNII: PL360EPO9J)
SUNFLOWER OIL (UNII: 3W1JG795YI)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
SODIUM CARBOXYMETHYL .BETA.-GLUCAN (DS 0.65-0.85) (UNII: 2YGO1190AP)
XANTHAN GUM (UNII: TTV12P4NEE)
DEHYDROXANTHAN GUM (UNII: 63ZP7I1BQO)
BENZOIC ACID (UNII: 8SKN0B0MIM)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
CHLORELLA VULGARIS (UNII: RYQ4R60M02)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
BENZYL ALCOHOL (UNII: LKG8494WBH)
LINALOOL, (+/-)- (UNII: D81QY6I88E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71056-110-02	1 in 1 PACKAGE	11/18/2016
1	NDC: 71056-110-01	12 mL in 1 SYRINGE, PLASTIC; 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(71056-110)

Establishment
Name	Address	ID/FEI	Business Operations
Goldeneye Permanent System Gmbh Germany		329178144	manufacture(71056-110)