NU-DERM SYSTEM NORMAL-DRY  SKIN TRANSFORMATION- hydroquinone, octinoxate, and zinc oxide 
OMP, 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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NU-DERM® SYSTEM
NORMAL DRY
Skin Transformation Kit

Clear (Skin Bleaching and Corrector Cream) NDC 62032-101-36 Net wt. 2 oz. (57 g) Hydroquinone USP, 4% Rx Only AM+PM

Dark spots may appear on the surface of your skin, but they actually start deep within the skin's layers. This gentle yet effective formula absorbs into the layers of your skin to deliver prescription-strength hydroquinone, helping to correct the appearance of age and sun spots for a healthier, more even complexion.

Indications and usage

The gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation.

Dosage and administration

Use daily, in the morning and evening. Squeeze a small amount (approximately 1-2 pea-size amounts) onto your hand. Apply evenly to the entire face, extending to the hairline, over the ears, and ending with a feathering motion, or as directed by your physician. If no improvement is seen after three (3) months of treatment, use of this product should be discontinued. Sun exposure should be limited by using a sunscreen agent, a sun blocking agent, or protective clothing to cover bleached skin when using and after using this product in order to prevent darkening from reoccurring.

Warnings

Avoid contact with eyes, nose, mouth, and lips. In case of accidental contact, patient should rinse thoroughly with water and contact a physician. Sunscreen use is an essential aspect of hydroquinone therapy because even minimal sunlight exposure sustains melanocytic activity.

Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

Each gram of Obagi Nu-Derm Clear contains:

Active ingredient

Hydroquinone USP, 4% (40 mg/g)

Inactive ingredients

water, cetyl alcohol, glycerin, sodium lauryl sulfate, stearyl alcohol, lactic acid, tocopheryl acetate, ascorbic acid, sodium metabisulfite, disodium EDTA, methylparaben, BHT, propylparaben, saponins, butylparaben

See enclosed Package Insert for full prescribing information.

Rx ONLY. FOR EXTERNAL USE ONLY.

Blender® (Skin Lightener and Blending Cream) NDC 62032-100-36 Net wt. 2 oz. (57 g) Hydroquinone USP, 4% Rx Only PM

A unique formula containing prescription-strength hydroquinone for the gradual lightening of sun spots, age spots, and other types of hyperpigmentation (discoloration). Specially formulated to optimize the delivery of product ingredients in the Nu-Derm System, this skin lightener helps reduce the signs of aging and correct uneven skin tone. May be used with Tretinoin Cream1 or Refissa®2 as prescribed by a physician.


1
Tretinoin cream is indicated for topical application in the treatment of acne vulgaris.
2
Refissa [Tretinoin Cream, USP (Emollient) 0.05%] is indicated as an adjunctive agent for use in the mitigation (palliation) of fine wrinkles, mottled hyperpigmentation, and tactile roughness of facial skin in patients who do not achieve such palliation using comprehensive skin care and sun avoidance programs. REFISSA DOES NOT ELIMINATE WRINKLES, REPAIR SUN-DAMAGED SKIN, REVERSE PHOTOAGING, or RESTORE A MORE YOUTHFUL or YOUNGER DERMAL HISTOLOGIC PATTERN.

Indications and usage

The gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation. Specially formulated for blending purposes as part of the Obagi Nu-Derm System.

Dosage and administration

Use daily, in the evening. Squeeze a small amount (approximately 1-2 pea-size drops) onto your hand. Apply evenly to the entire face, or as directed by your skin care physician. If no improvement is seen after three (3) months of treatment, use of this product should be discontinued. Sun exposure should be limited by using a sunscreen agent, a sun blocking agent, or protective clothing to cover bleached skin when using and after using this product in order to prevent darkening from reoccurring.

Warnings

Avoid contact with eyes, nose, mouth, and lips. In case of accidental contact, patient should rinse thoroughly with water and contact a physician. Sunscreen use is an essential aspect of hydroquinone therapy because even minimal sunlight exposure sustains melanocytic activity.

Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

Each gram of Obagi Nu-Derm Blender contains:

Active ingredient

Hydroquinone USP, 4% (40 mg/g)

Inactive ingredients

water, glycerin, cetyl alcohol, PPG-2 myristyl ether propionate, sodium lauryl sulfate, TEA-salicylate, lactic acid, phenyl trimethicone, tocopheryl acetate, sodium metabisulfite, ascorbic acid, methylparaben, disodium EDTA, propylparaben, saponins, BHT

See enclosed Package Insert for full prescribing information.

Rx ONLY. FOR EXTERNAL USE ONLY.

Travel Bag and Patient Instruction Guide

Store at controlled room temperature 15°C–25°C (59°F–77°F).

Obagi Hydrate is a trademark, and Blender, Exfoderm, Nu-Derm, and the Obagi logo are registered trademarks, of OMP, Inc.

Refissa is a registered trademark of Spear Pharmaceuticals, Inc.
Distributed by OMP, Inc., Long Beach, CA 90806

©2012 Obagi Medical Products, Inc. All rights reserved.
obagi.com Made in USA 41706111Z 7061

Sun Shield Broad Spectrum SPF 50 Matte Net wt. 3 oz. (85 g)

This sunscreen combines UVB absorption and UVA protection in an elegant matte finish that is non-comedogenic, hypoallergenic, non-acnegenic, and dermatologist tested. Sheer, PABA free, and fragrance free for all skin types.

Drug Facts

Active ingredients

Octinoxate 7.5%
Zinc Oxide 10.5%

Purpose

Sunscreen

Uses

Warnings

For external use only

Do not use on damaged or broken skin

Stop use and ask a doctor if rash occurs

When using this product keep out of eyes. Rinse with water to remove.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Inactive ingredients

1,2 hexanediol, caprylyl glycol, ceteareth-20, cetearyl alcohol, chlorphenesin, citric acid, cyclopentasiloxane, dimethicone, dimethicone crosspolymer-3, disodium EDTA, glycerin, hydrogenated palm glycerides, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, methylisothiazolinone, PEG-40 stearate, pentylene glycol, phenoxyethanol, phenyl trimethicone, polysilicone-11, polysorbate 60, potassium sorbate, sodium benzoate, sodium dihydroxycetyl phosphate, sodium polyacrylate, squalane, stearyl alcohol, tetrahexyldecyl ascorbate, tropolone, water, xanthan gum

Other information

Questions or comments?

1.800.636.7546
Monday–Friday 9 a.m.–4 p.m. Pacific Time

PRINCIPAL DISPLAY PANEL - Kit Carton

NDC# 62032-520-00

OBAGI®
MEDICAL

NU-DERM® SYSTEM

NORMAL DRY

Skin Transformation Kit

PRINCIPAL DISPLAY PANEL - Kit Carton
NU-DERM SYSTEM NORMAL-DRY   SKIN TRANSFORMATION
hydroquinone, octinoxate, and zinc oxide kit
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:62032-520
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62032-520-001 in 1 CARTON
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE, PLASTIC 57 g
Part 21 BOTTLE, PLASTIC 57 g
Part 31 TUBE 85 g
Part 41 BOTTLE, PLASTIC 198 mL
Part 51 BOTTLE, PLASTIC 198 mL
Part 61 BOTTLE, PLASTIC 57 g
Part 71 BOTTLE, PLASTIC 48 g
Part 1 of 7
NU-DERM BLENDER   SKIN LIGHTENER AND BLENDING
hydroquinone cream
Product Information
Item Code (Source)NDC:62032-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
EDETATE DISODIUM (UNII: 7FLD91C86K)  
PPG-2 MYRISTYL ETHER PROPIONATE (UNII: 88R97D8U8A)  
TROLAMINE SALICYLATE (UNII: H8O4040BHD)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERIN (UNII: PDC6A3C0OX)  
LACTIC ACID (UNII: 33X04XA5AT)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
WATER (UNII: 059QF0KO0R)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62032-100-3657 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other01/01/1988
Part 2 of 7
NU-DERM CLEAR   SKIN BLEACHING AND CORRECTOR
hydroquinone cream
Product Information
Item Code (Source)NDC:62032-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
EDETATE DISODIUM (UNII: 7FLD91C86K)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERIN (UNII: PDC6A3C0OX)  
LACTIC ACID (UNII: 33X04XA5AT)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
WATER (UNII: 059QF0KO0R)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62032-101-3657 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other01/01/1988
Part 3 of 7
NU-DERM SUN SHIELD BROAD SPECTRUM SPF 50 MATTE   SUNSCREEN
octinoxate and zinc oxide lotion
Product Information
Item Code (Source)NDC:62032-126
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE105 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
SQUALANE (UNII: GW89575KF9)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
PEG-40 STEARATE (UNII: ECU18C66Q7)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
SODIUM DIHYDROXYCETYL PHOSPHATE (UNII: YWI33EV595)  
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
TROPOLONE (UNII: 7L6DL16P1T)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62032-126-9085 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35202/21/2013
Part 4 of 7
NU-DERM GENTLE CLEANSER 
cleansing (cold creams, cleansing lotions, liquids, and pads) liquid
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER (UNII: 059QF0KO0R)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
INGRMETHYLPARABEN (UNII: A2I8C7HI9T)  
INGRPROPYLPARABEN (UNII: Z8IX2SC1OH)  
INGRBUTYLPARABEN (UNII: 3QPI1U3FV8)  
INGRETHYLPARABEN (UNII: 14255EXE39)  
INGRISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
INGRCARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
INGRSODIUM LAUROYL OAT AMINO ACIDS (UNII: FSW2K9B9N5)  
INGRCOCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
INGRSODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
INGRALOE VERA LEAF (UNII: ZY81Z83H0X)  
INGRGLYCERETH-7 (UNII: 3D2Y91QZ2H)  
INGRPANTHENOL (UNII: WV9CM0O67Z)  
INGRDIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
INGRTROLAMINE (UNII: 9O3K93S3TK)  
INGRSAGE (UNII: 065C5D077J)  
INGRFD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
INGRAPRICOT KERNEL OIL (UNII: 54JB35T06A)  
Product Characteristics
ColorYELLOWScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1198 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic01/01/1988
Part 5 of 7
NU-DERM TONER 
face and neck (excluding shaving preparations) liquid
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER (UNII: 059QF0KO0R)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRHAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)  
INGRSODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
INGRDMDM HYDANTOIN (UNII: BYR0546TOW)  
INGRIODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
INGRPOTASSIUM ALUM (UNII: 1L24V9R23S)  
INGRPANTHENOL (UNII: WV9CM0O67Z)  
INGRSAGE (UNII: 065C5D077J)  
INGRCALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
INGRPOLYSORBATE 80 (UNII: 6OZP39ZG8H)  
INGRALLANTOIN (UNII: 344S277G0Z)  
INGRALOE VERA LEAF (UNII: ZY81Z83H0X)  
INGRFD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Product Characteristics
ColorBLUEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1198 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic01/01/1988
Part 6 of 7
NU-DERM EXFODERM 
face and neck (excluding shaving preparations) lotion
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER (UNII: 059QF0KO0R)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRDIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
INGRMETHYLPARABEN (UNII: A2I8C7HI9T)  
INGRPROPYLPARABEN (UNII: Z8IX2SC1OH)  
INGRPOLYSORBATE 60 (UNII: CAL22UVI4M)  
INGRCETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
INGRSTEARETH-20 (UNII: L0Q8IK9E08)  
INGRCANOLA OIL (UNII: 331KBJ17RK)  
INGRISOHEXADECANE (UNII: 918X1OUF1E)  
INGRMAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
INGRCETYL ALCOHOL (UNII: 936JST6JCN)  
INGRFYTIC ACID (UNII: 7IGF0S7R8I)  
INGRGLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
INGRPEG-100 STEARATE (UNII: YD01N1999R)  
INGRDIMETHICONE (UNII: 92RU3N3Y1O)  
INGRPEG-150 STEARATE (UNII: 7BSG7DF10Q)  
INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
INGRBUTYLPARABEN (UNII: 3QPI1U3FV8)  
INGRETHYLPARABEN (UNII: 14255EXE39)  
INGRISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
INGRPOTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
INGRXANTHAN GUM (UNII: TTV12P4NEE)  
INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
INGRGLYCERETH-7 (UNII: 3D2Y91QZ2H)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
157 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic01/01/1988
Part 7 of 7
NU-DERM HYDRATE   FACIAL MOISTURIZER
face and neck (excluding shaving preparations) lotion
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER (UNII: 059QF0KO0R)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRMEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
INGRCAESALPINIA SPINOSA RESIN (UNII: WL3883U2PO)  
INGRSHEA BUTTER (UNII: K49155WL9Y)  
INGRGLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
INGRCYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
INGRCETYL ALCOHOL (UNII: 936JST6JCN)  
INGRSACCHARIDE ISOMERATE (UNII: W8K377W98I)  
INGRDIMETHICONE (UNII: 92RU3N3Y1O)  
INGRTOCOPHEROL (UNII: R0ZB2556P8)  
INGRLAURETH-12 (UNII: OAH19558U1)  
INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
INGRETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
INGRSTEARIC ACID (UNII: 4ELV7Z65AP)  
INGRAVOCADO OIL (UNII: 6VNO72PFC1)  
INGRSOY STEROL (UNII: PL360EPO9J)  
INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
INGRLEVOMENOL (UNII: 24WE03BX2T)  
INGRHEXYLENE GLYCOL (UNII: KEH0A3F75J)  
INGRTETRAHYDRODIFERULOYLMETHANE (UNII: 00U0645U03)  
INGRPANTHENOL (UNII: WV9CM0O67Z)  
INGRMANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
INGRSODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
INGRCARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
INGRALLANTOIN (UNII: 344S277G0Z)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
148 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic11/07/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other04/15/2013
Labeler - OMP, INC. (790553353)
Establishment
NameAddressID/FEIBusiness Operations
Bay Cities Container Corporation066229618RELABEL(62032-520) , REPACK(62032-520)
Establishment
NameAddressID/FEIBusiness Operations
PURETEK CORPORATION785961046MANUFACTURE(62032-520) , LABEL(62032-520) , PACK(62032-520)
Establishment
NameAddressID/FEIBusiness Operations
Ei INC.105803274MANUFACTURE(62032-520) , LABEL(62032-520) , PACK(62032-520) , ANALYSIS(62032-520)
Establishment
NameAddressID/FEIBusiness Operations
G.S. COSMECEUTICAL USA, INC.017014734MANUFACTURE(62032-520)

Revised: 8/2013
Document Id: 1be2dfad-d98e-4b0d-9d07-4820deb8e2aa
Set id: 0d91be8e-1553-4ef7-b333-724c0e27651e
Version: 1
Effective Time: 20130815
 
OMP, INC.