Label: SEEQUIN 2- hydroquinone liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 67226-2620-3 - Packager: Vivier Pharma, Inc.
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated November 6, 2013
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- Active Ingredient
- Indication
- Indication
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Precautions
For external use only. A mild transient stinging may occur for people with sensitive skin. Do not use on broken or irritated skin. Discontinue use if irritation or rash occurs. Avoid contact with eyes and mucous membranes. In case of contact, rinse thoroughly with water. Do not use on children under 12 years of age. Keep out of reach of children. Avoid use around the eyes and lips.
- Precautions
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Directions
Remove and discard solid white cap from bottle and replace with dropper cap. Test for skin sensitivity before using by applying 1 or 2 drops of SEEQUIN™ 2 IDS™ Liquid Gel S-erum * to an area of unbroken skin about 25 mm in diameter. If excessive irritation, rash or other reaction develops within 24 hours, discontinue use. To apply, place 1 to 2 drops of SEEQUIN™ 2 IDS™ Liquid Gel S-erum* in the palm of your hand and use fingertips to apply a thin layer to the affected areas. Use both morning and night or as directed by a physician. Depigmentation is a gradual process and results should be expected within 12 weeks of daily use. Discontinue use if no results are apparent after 8 weeks. To maintain results, use several times per week or as directed by a physician. Limit sun exposure during treatment by using protective clothing or a sunscreen protective agent to avoid re-darkening of the skin. Close dropper cap securely after each use. Store at room temperature (15-25°C / 59-77°F).
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INGREDIENTS AND APPEARANCE
SEEQUIN 2
hydroquinone liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67226-2620 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 GRAPEFRUIT (UNII: O82C39RR8C) DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) ASCORBIC ACID (UNII: PQ6CK8PD0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67226-2620-3 1 in 1 BOX 1 30 mL in 1 BOTTLE, DROPPER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part358A 09/01/2013 Labeler - Vivier Pharma, Inc. (250996550) Establishment Name Address ID/FEI Business Operations Vivier Pharma, Inc. 250996550 manufacture(67226-2620)