SEEQUIN 4- hydroquinone liquid 
Vivier Pharma, Inc.

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.

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Seequin 4

Active Ingredient

Hydroquinone USP (4%)

Indication

Skin Lightening

Indication

To gradually lighten hyperpigmentation of the skin such as age spots, liver spots, freckles or other areas of unwanted melanin hyperpigmentation that may occur in pregnancy or from the use of oral contraceptives.

Precautions

For external use only. A mild transient stinging may occur for people with sesitive skin. Do not use onbroken or irritated skin. Discontinue use if irritation or rash occurs. Avoid contct with eyes and mucous membranes. In case of contact rinse thoroughly with water. Do not use on children under 12 years of age. Keep away from children. Avoid use around the eyes and lips.

Precautions

Keep away from children.

Directions

Remove and discard solid white cap from bottle and replace with dropper. To apply, place 1 to 2 drops of SEEQUIN™ 4 IDS ™ (Skin Lightening) Liquid Gel S-e rum* in palm of hand and use fingertips to apply a thin layer to affected areas. Use both morning and night or as directed by a physician. Gradual lightening of the discoloration can be expected in most cases. Close dropper cap securely after each use. Store at room temperature (15-25ºC / 59-77ºF).

Non-Medicinal Ingredients

CITRUS GRANDIS (GRAPEFRUIT) EXTRACT, ETHOXYDIGLYCOL, FRAGRANCE, HYDROQUINONE USP, L-ASCORBIC ACID USP, PROPYLENE GLYCOL, WATER/EAU.

Principal Display Panel

SEEQUIN 4_PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SEEQUIN 4 
hydroquinone liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67226-1040
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GRAPEFRUIT (UNII: O82C39RR8C)  
DIETHYLENE GLYCOL MONOMETHYL ETHER (UNII: 465DDJ8G8K)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67226-1040-31 in 1 BOX
130 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart358A05/30/2014
Labeler - Vivier Pharma, Inc. (250996550)
Establishment
NameAddressID/FEIBusiness Operations
Vivier Pharma, Inc.250996550manufacture(67226-1040)

Revised: 11/2013
Document Id: 0fbce541-7cea-4523-83b3-bc8ef2a066f2
Set id: b76aec2e-4276-4661-b225-ccff4fcf112b
Version: 2
Effective Time: 20131107
 
Vivier Pharma, Inc.