DR. THROWERS PBC NO. 1- hydroquinone, tretinoin, betamethasone dipropionate cream
DR. THROWER'S SKINCARE, 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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DIRECTIONS:

APPLY IN A VERY THIN LAYER IN THE DARK AREA ONLY. FOR DARK SPOTS APPLY TO THE CENTER OF DARK SPOTS.

FREQUENCY OF APPLICATION: DETERMINED BY DR. THROWER.

USES:

EXTREME SKIN DISCOLORATION AND DARK SPOTS.

INGREDIENTS:

Aqua, Ceteraryl Alcohol, Sodium Cetearyl Sulfate, Caprylic/Capric Triglyceride,Cyclopentasiloxane, Cyclohexasiloxane, Propylene Glycol, Butylene Glycol , Hydrogenated Lecithin,Sodium Oleate , Oligopeptide-68, Propanediol, Boerhavia Diffusa Root Extract ,Alcohol Denatured, Decyl Oleate, Hydrogenated Elaesis Guineensis (Palm Kernal) Oil, Hydrogenated Glycine Soja (Soybean) Oil, Hydrogenated Gossypium Herbaceum (Cotton) Seed Oil, Lecithin, Diazolidinyl Urea , Methylparaben, Propylparaben,Sodium Metabisulfite, Tocopheryl Acetate, Disodium EDTA, Sodium Hyaluronate, , Citric Acid , Aloe Barbadensis (Aloe) Leaf Juice

WARNINGS

STOP USE IF SKIN BECOMES IRRITATED (PINK, RED DARKER, OR EXCESSIVE PEELING). FOR EXTERNAL USE ONLY. KEEP OUT OF REACH OF CHILDREN. FEDERAL LAW PROHIBITS THE TRANSFER OF THIS DRUG TO ANY OTHER PERSON OTHER THAN FOR WHOM IT IS PRESCRIBED.

PBC-1 Label

DR. THROWERS PBC NO. 1
hydroquinone, tretinoin, betamethasone dipropionate cream

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:69299-301
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE)	HYDROQUINONE	12 g in 100 g
TRETINOIN (UNII: 5688UTC01R) (TRETINOIN - UNII:5688UTC01R)	TRETINOIN	0.1 g in 100 g
BETAMETHASONE DIPROPIONATE (UNII: 826Y60901U) (BETAMETHASONE - UNII:9842X06Q6M)	BETAMETHASONE	0.5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
SODIUM OLEATE (UNII: 399SL044HN)
AMINO ACIDS (UNII: 0O72R8RF8A)
PROPANEDIOL (UNII: 5965N8W85T)
BOERHAVIA DIFFUSA ROOT (UNII: KR0SR09KYL)
ALCOHOL (UNII: 3K9958V90M)
DECYL OLEATE (UNII: ZGR06DO97T)
HYDROGENATED PALM KERNEL OIL (UNII: FM8D1RE2VP)
HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)
HYDROGENATED COTTONSEED OIL (UNII: Z82Y2C65EA)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
EDETATE DISODIUM (UNII: 7FLD91C86K)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69299-301-21	28 g in 1 JAR; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		05/15/2015

Labeler - DR. THROWER'S SKINCARE, INC. (078711495)

Registrant - DR. THROWER'S SKINCARE, INC. (078711495)