Label: PIONA- hydroquinone lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 52927-200-01 - Packager: Grand Stream Enterprise, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated December 7, 2016
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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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
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- INDICATIONS & USAGE
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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
- PURPOSE
- PIONA Skin Lightening Body Lotion
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INGREDIENTS AND APPEARANCE
PIONA
hydroquinone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52927-200 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE 1.95 in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:52927-200-01 296 mL in 1 TUBE; Type 0: Not a Combination Product 11/01/2016 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 Business Operations JIC SKIN KOREA CO.,LTD. 557837776 MANUFACTURE(52927-200)
