VIVANT TRUE TONE FORTE- hydroquinone gel

Vivant True Tone Forte by

Drug Labeling and Warnings

Vivant True Tone Forte by is a Otc medication manufactured, distributed, or labeled by Vivant Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Hydroquinone (2%)

Indication

Skin Lightening

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

Alcohol Denat, Ethoxydiglycol, Ethylhexyl Dimethyl PABA Hydroquinone USP, Kojic Acid USP, Citric Acid USP, Retinyl Propionate

Propylene Glycol, Hydroxypropylcellulose

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

Principal Display Panel

INGREDIENTS AND APPEARANCE

VIVANT TRUE TONE FORTE 
hydroquinone gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63750-001
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
ALCOHOL (UNII: 3K9958V90M)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
PADIMATE O (UNII: Z11006CMUZ)
KOJIC ACID (UNII: 6K23F1TT52)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
RETINYL PROPIONATE (UNII: 32JK994WMC)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE (11% HYDROXYPROPYL; 140000 MW) (UNII: 599BTP6K9F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63750-001-01	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(63750-001)