PIONA: Package Insert and Label Information

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.

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
(click image for full-size original)
PIONA
hydroquinone lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52927-200
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROQUINONE (HYDROQUINONE) HYDROQUINONE 1.95 in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
MINERAL OIL
GLYCERIN
BUTYLENE GLYCOL
BETAINE
NIACINAMIDE
CETOSTEARYL ALCOHOL
GLYCERYL MONOSTEARATE
OLIVE OIL
SODIUM LAURYL SULFATE
POLYSORBATE 60
PEG-100 STEARATE
DIMETHICONE
ALLANTOIN
XANTHAN GUM
SODIUM BISULFATE
SODIUM METABISULFITE
SODIUM ASCORBYL PHOSPHATE
GLYCYRRHIZA GLABRA
BLACK COHOSH
FALLOPIA MULTIFLORA ROOT
SESAME SEED
PHELLINUS LINTEUS MYCELIUM
ANGELICA GIGAS ROOT
MORUS ALBA BARK
PAEONIA LACTIFLORA ROOT
SOPHORA FLAVESCENS ROOT
SCUTELLARIA BAICALENSIS ROOT
PUNICA GRANATUM ROOT BARK
INDIGOFERA TINCTORIA LEAF
GREEN TEA LEAF
COPTIS CHINENSIS ROOT
GARLIC
ASIAN GINSENG
RICE GERM
METHYLPARABEN
PROPYLPARABEN
GLYCOLIC ACID
EDETATE DISODIUM ANHYDROUS
SAFFLOWER
STEARIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52927-200-01 296 mL in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part358A 11/01/2016
Labeler — Grand Stream Enterprise, Inc (805697948)
Establishment
Name Address ID/FEI Operations
JIC SKIN KOREA CO.,LTD. 557837776 MANUFACTURE (52927-200)

Revised: 12/2016 Grand Stream Enterprise, Inc

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