VIVANT TRUE TONE- hydroquinone cream 
Vivant Pharmaceuticals, LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Vivant True Tone (Export Only)

Active Ingredient

Hydroquinone (2%)

Indication

Skin Bleaching Agent

Uses

Uses

■ For the gradual fading of age spots

■ Lightens dark pigment in the skin

■This product provides minimal SPF protection.

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.

Ask a doctor if you are:

using other topical acne medications

Directions

Directions ■ Adult topical dosage is a thin layer to the affected area once or twicedaily■There is no recommended dosage for children under 12 years of age except under the advice and supervision of a doctor ■ Keep refrigerated

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

When using this product

if not improvement is seen after 2 months of treatment, use of this products should be discontinued

Stop use and ask the doctor if

excessive skin irritation develops or increases

Warnings

Keep out of reach of children■For external only■Not recommended for children under12 years of age

Other Information

Other Information• Depigmentation(lightening) effect of this product may not be noticeable when used on very dark skin

This product will bleach skin and is not for the prevention of sunburn.

Principal Display Panel

label

VIVANT TRUE TONE 
hydroquinone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63750-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63750-002-011 in 1 BOX02/01/2024
130 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/01/2024
Labeler - Vivant Pharmaceuticals, LLC (782696814)
Establishment
NameAddressID/FEIBusiness Operations
Vivant Pharmaceuticals, LLC782696814manufacture(63750-002)

Revised: 2/2024
Document Id: 10bc7c26-d6dc-e262-e063-6294a90a7332
Set id: 10bc7194-0af6-3d77-e063-6394a90aea20
Version: 1
Effective Time: 20240206
 
Vivant Pharmaceuticals, LLC