PIONA- hydroquinone lotion 
Grand Stream Enterprise, Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ACTIVE INGREDIENT

HYDROQUINONE 1.95%...............................................Skin Bleaching

INACTIVE INGREDIENT

ALLANTOIN, ANGELICA GIGAS ROOT, ASIAN GINSENG, BETAINE, BLACK COHOSH, BUTYLENE GLYCOL, CETOSTEARYL ALCOHOL, COPTIS CHINENSIS ROOT, DIMETHICONE, EDETATE DISODIUM ANHYDROUS, FALLOPIA MULTIFLORA ROOT, GARLIC, GLYCERIN, GLYCERYL MONOSTEARATE, GLYCOLIC ACID, GLYCYRRHIZA GLABRA, GREEN TEA LEAF, INDIGOFERA TINCTORIA LEAF, METHYLPARABEN, MINERAL OIL, MORUS ALBA BARK, NIACINAMIDE, OLIVE OIL, PAEONIA LACTIFLORA ROOT, PEG-100 STEARATE, PHELLINUS LINTEUS MYCELIUM, POLYSORBATE 60, PROPYLPARABEN, PUNICA GRANATUM ROOT BARK, RICE GERM, SAFFLOWER, SCUTELLARIA BAICALENSIS ROOT, SESAME SEED, SODIUM ASCORBYL PHOSPHATE, SODIUM BISULFATE, SODIUM LAURYL SULFATE, SODIUM METABISULFITE, SOPHORA FLAVESCENS ROOT, STEARIC ACID, WATER, XANTHAN GUM

KEEP OUT OF REACH OF CHILDREN

INDICATIONS & USAGE

Gracually fades skin discolorations such as age spots, freckles and scars.

WARNINGS

Sun exposure should be limited by using a sunscreen agent, a sun blocking agent, or protective clothing to cover bleached skin after treatments completed in order to prevent darkening from reoccurring.
Avoid contact with eyes.
Some users of this product may experience a mild ski, irritation. If ski, irritation becomes severe, stop use and consult a doctor.
If pregnant or breast-feeding, ask a health professional before use.
If swallowed, get medical help or contact a Poison Control center right away.

DOSAGE & ADMINISTRATION

Adults: apply a small amount as a thin layer on the affected area twice daily, or use as drected by a doctor. If no improvement is seen after 3 months of treatment use of this product should be discontinued.

PURPOSE

Skin Bleaching

PIONA Skin Lightening Body Lotion

Questions or Comments? 954-731-0165 or piona@grandstreament.com
Formulated in France
Made in Korea
Distributed by: Grand Stream Enterprise, Inc. 2219 NW 29 St., Oakland Park, FL 33311

Label Image
PIONA 
hydroquinone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52927-200
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE1.95   in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
MINERAL OIL (UNII: T5L8T28FGP)  
GLYCERIN (UNII: PDC6A3C0OX)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
BETAINE (UNII: 3SCV180C9W)  
NIACINAMIDE (UNII: 25X51I8RD4)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
PEG-100 STEARATE (UNII: YD01N1999R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ALLANTOIN (UNII: 344S277G0Z)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SODIUM BISULFATE (UNII: BU8V88OWIQ)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
BLACK COHOSH (UNII: K73E24S6X9)  
FALLOPIA MULTIFLORA ROOT (UNII: AUZ3VD75MC)  
SESAME SEED (UNII: 7Y1255HVXR)  
PHELLINUS LINTEUS MYCELIUM (UNII: 40K19XJV3C)  
ANGELICA GIGAS ROOT (UNII: 32766B2FHX)  
MORUS ALBA BARK (UNII: 7O71A48NDP)  
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)  
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)  
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)  
INDIGOFERA TINCTORIA LEAF (UNII: 2K7DF8HZDM)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
COPTIS CHINENSIS ROOT (UNII: CXS4LJR7EL)  
GARLIC (UNII: V1V998DC17)  
ASIAN GINSENG (UNII: CUQ3A77YXI)  
RICE GERM (UNII: 7N2B70SFEZ)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
GLYCOLIC ACID (UNII: 0WT12SX38S)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
SAFFLOWER (UNII: 4VBL71TY4Y)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52927-200-01296 mL in 1 TUBE; Type 0: Not a Combination Product11/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart358A11/01/2016
Labeler - Grand Stream Enterprise, Inc (805697948)
Establishment
NameAddressID/FEIBusiness Operations
JIC SKIN KOREA CO.,LTD.557837776MANUFACTURE(52927-200)

Revised: 12/2016
Document Id: 56e7d6ee-0c00-46d0-a7fb-2dab60b3199f
Set id: 34395fc1-41bf-42b6-b4f0-14d62eeb97b3
Version: 3
Effective Time: 20161207
 
Grand Stream Enterprise, Inc