Label: VIVANT TRUE TONE- hydroquinone cream
- NDC Code(s): 63750-002-01
- Packager: Vivant Pharmaceuticals, LLC
- Category: HUMAN OTC DRUG LABEL
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Drug Label Information
Updated February 6, 2024
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- Active Ingredient
- Indication
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Warnings
Warnings ■Sun exposure should be avoided indefinitely by using a high SPF sunscreen agent, a sunblocking agent, or protective clothing to cover bleached skin in order to prevent darkening from reoccurring ■ Do not get into eyes ■Keep out of reach of
children ■For external use only ■Not recommended for children under 12 years of age ■ If swallowed get medical help or contact a poison control center immediately.
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- Directions
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Inactive Ingredients
Inactive Ingredients• Water, Mineral Oil, Propylene Glycol, Glyceryl Stearate, PEG-10O Stearate, Vitis Vinifera (Grape Seed) Seed Oil, Cetyl Alcohol, Emulsifying Wax, Caprylic/Capric Triglyceride, Retinyl Propionate, Kojic Acid, EthylhexylDimethyl PABA, Dimethicone, HydrolyzedOat Protein, Aloe Barbadensis Leaf Juice, Polyacrylamide, C13-14 isoparaffin, Laureth-7, Xanthan Gum, Sodium Hydroxide, Sodium Metabisulfite, Sodium Bisullte, Phenoxyethanol, Ethylhexylglycerin
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- Stop use and ask the doctor if
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INGREDIENTS AND APPEARANCE
VIVANT TRUE TONE
hydroquinone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63750-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE 2 g in 100 mL Inactive Ingredients Ingredient Name Strength ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) SODIUM METABISULFITE (UNII: 4VON5FNS3C) PADIMATE O (UNII: Z11006CMUZ) VITIS VINIFERA LEAF OIL (UNII: 76K69S9H5Z) CETYL ALCOHOL (UNII: 936JST6JCN) WATER (UNII: 059QF0KO0R) KOJIC ACID (UNII: 6K23F1TT52) ALOE VERA LEAF (UNII: ZY81Z83H0X) RETINYL PROPIONATE (UNII: 32JK994WMC) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) AVENA SATIVA LEAF (UNII: 206PI19V7R) SODIUM HYDROXIDE (UNII: 55X04QC32I) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) SODIUM BISULFITE (UNII: TZX5469Z6I) DIMETHICONE (UNII: 92RU3N3Y1O) PHENOXYETHANOL (UNII: HIE492ZZ3T) GLYCERYL 1-STEARATE (UNII: 258491E1RZ) PEG-60 STEARATE (UNII: 7TB32G765E) POLYSORBATE 60 (UNII: CAL22UVI4M) MINERAL OIL (UNII: T5L8T28FGP) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63750-002-01 1 in 1 BOX 02/01/2024 1 30 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 02/01/2024 Labeler - Vivant Pharmaceuticals, LLC (782696814) Establishment Name Address ID/FEI Business Operations Vivant Pharmaceuticals, LLC 782696814 manufacture(63750-002)