Label: ADVANCED SKIN LIGHTENING SERUM- hydroquinone gel
- NDC Code(s): 67226-2622-3
- Packager: Vivier Pharma, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated December 27, 2017
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- Drug facts
- Active ingredient
For external use only.
Use only on the advice of a physician.
Do not use
• On broken or irritated skin.
• On children under 12 years of age.
• If you are pregnant, nursing or you intend to become pregnant within 3 months of use.
Sunburn alert:Limit sun exposure during treatment by using protective clothing or a sunscreen protective agent to avoid re-darkening of the skin.
When using this product
• A mild transient stinging may occur for people with sensitive skin.
• Gradual lightening of the discolored area can be expected in most cases.
• Avoid contact with eyes and mucous membranes. In case of contact, rinse thoroughly with water.
• Remove and discard white cap and replace with dropper.
• To apply, place 1 to 2 drops of ADVANCED SKIN LIGHTENING SERUM 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.
• Close cap securely after each use.
• Close dropper cap securely after each use.
Information pharmaceutique (suite)
- Other information / Autres renseignements
- Inactive ingredients
- Package Labeling:
INGREDIENTS AND APPEARANCE
ADVANCED SKIN LIGHTENING SERUM
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67226-2622 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE 20 mg in 1 mL Inactive Ingredients Ingredient Name Strength GRAPEFRUIT (UNII: O82C39RR8C) DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67226-2622-3 30 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/06/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part358A 11/06/2017 Labeler - Vivier Pharma, Inc. (250996550)