Active Ingredient
Hydroquinone (2%)
Vivant True Tone Forte Gel
FDA Label NDC 63750-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Vivant Pharmaceuticals, Llc for the product Vivant True Tone Forte (NDC 63750-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, indication, uses, warnings, ask a doctor if you are:, directions, inactive ingredients, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
Keep out of reach of children■For external only■Not recommended for children under12 years of age
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
* Please review the disclaimer below.
