SKIN LIGHTENING COMPLEX- hydroquinone cream 
Vi Medical Products Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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SKIN LIGHTENING COMPLEX

USE

HELPS LIGHTEN DARK PATCHES OF SKIN SUCH AS AGE SPOTS, MELASMA, FRECKLES AND HYPERPIGMENTATION THAT CAN OCCUR AS A RESULT OF PREGNANCY, USE OF ORAL CONTRACEPTIVES OR INJURY TO THE SKIN. RX ONLY. FOR EXTERNAL USE ONLY.

01b LBL_Skin Lightening Complex_HQ 4pct

01b LBL_Skin Lightening Complex_HQ 4pct_Panel 101b LBL_Skin Lightening Complex_HQ 4pct_Panel 1

SKIN LIGHTENING COMPLEX 
hydroquinone cream
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70484-101
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
ARBUTIN (UNII: C5INA23HXF)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
AZELAIC ACID (UNII: F2VW3D43YT)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
KOJIC DIPALMITATE (UNII: 13N249RWTM)  
MALIC ACID (UNII: 817L1N4CKP)  
MALVA SYLVESTRIS FLOWERING TOP (UNII: X1U1U0N90J)  
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
PEG-100 STEARATE (UNII: YD01N1999R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
EDETATE SODIUM (UNII: MP1J8420LU)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70484-101-1250 mL in 1 BOTTLE; Type 0: Not a Combination Product07/29/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other07/28/2019
Labeler - Vi Medical Products Inc. (063910521)
Registrant - Vi Medical Products Inc. INC (063910521)
Establishment
NameAddressID/FEIBusiness Operations
MICRO CONNECTION ENTERPRISES INC144297160manufacture(70484-101)

Revised: 8/2019
Document Id: d5b839b9-dae2-4b92-897b-2a91b8910f28
Set id: 2f5a208d-b138-4b90-9ffe-eb58887d660e
Version: 2
Effective Time: 20190807
 
Vi Medical Products Inc.