POLARIS RESEARCH NR-02 HAIR REGROWTH- minoxidil shampoo

Polaris Research NR-02 Hair Regrowth by

Drug Labeling and Warnings

Polaris Research NR-02 Hair Regrowth by is a Otc medication manufactured, distributed, or labeled by DS Healthcare Group, A.I.G. TECHNOLOGIES, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Minoxidil 1.5% W/W

PURPOSE

HAIR REGROWTH SHAMPOO FOR MEN

Use

Polaris NR-02® Shampoo is for men only. Women should not use or handle this product.

Warning

For external use only. Avoid eye contact. This product is not for women.Finasteride has been shown to cause birth defects in women who are pregnant or may become pregnant. Be sure this product is never handled or used by women.

Keep out of reach of children.
Minoxidil has been shown to increase unwanted body hair. Use as directed.

KEEP OUT OF REACH OF CHILDREN

DIRECTIONS

Apply Polaris NR-02® Shampoo to wet hair, lather, and rinse. Repeat and leave on scalp for 1-2 minutes. Use daily to control hair loss.

Inactive ingredients

WATER, DISODIUM LAURETH SULFOSUCCINATE, SODIUM COCOYL ISETHIONATE, COCAMIDOPROPYL HYDROXYSULTAINE, SODIUM LAUROYL
SARCOSINATE, AMODIMETHICONE, C11-15 PARETH-7, GLYCERIN, LAURETH-9, PEG-150 DISTEARATE, TRIDECETH-12, COCAMIDE MEA,
DI-PPG2 MYRETH-10 ADIPATE, SODIUM LAURYL SULFOACETATE, COCAMIDOPROPYLAMINE OXIDE, GLYCOL DISTEARATE, MINOXIDIL,
CAFFEINE, POLYSORBATE 20, KETOCONAZOLE, FINASTERIDE, BIOTIN, COPPER TRIPEPTIDE-1,TOCOPHEROL, RETINYL PALMITATE, AESCULUS
HIPPOCASTANUM (HORSE CHESTNUT) SEED EXTRACT, ASPALATHUS LINEARIS LEAF EXTRACT, HYDROLYZED SOY PROTEIN,HYDROLYZED WHEAT PROTEIN, WHEAT AMINO ACIDS, INOSITOL, PHENOXYETHANOL,CINNAMIDOPROPYLTRIMONIUM CHLORIDE,HYDROLYZED PROANTHOCYANIDIN, CAPRYLYL GLYCOL, METHYL SULFONYL METHANE,ALCOHOL DENAT, CALCIUM PANTOTHENATE,LINOLEIC ACID, PEG-35 CASTOR OIL,
POLYQUATERNIUM 10 , TAURINE, TETRASODIUM EDTA, ETHYLBISIMINOMETHYLGUAIACOLMANGANESE CHLORIDE, FRAGRANCE CITRIC ACID

Product label

INGREDIENTS AND APPEARANCE

POLARIS RESEARCH NR-02 HAIR REGROWTH 
minoxidil shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69188-400
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1)	MINOXIDIL	1.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)
COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
AMODIMETHICONE (800 CST) (UNII: 363Z2T48P7)
C11-15 PARETH-7 (UNII: 261HPE0IS3)
GLYCERIN (UNII: PDC6A3C0OX)
POLIDOCANOL (UNII: 0AWH8BFG9A)
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)
TRIDECETH-12 (UNII: YFY3KG5Y7O)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
DI-PPG-2 MYRETH-10 ADIPATE (UNII: 4IN301M0KJ)
SODIUM LAURYL SULFOACETATE (UNII: D0Y70F2B9J)
COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
CAFFEINE (UNII: 3G6A5W338E)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
KETOCONAZOLE (UNII: R9400W927I)
FINASTERIDE (UNII: 57GNO57U7G)
BIOTIN (UNII: 6SO6U10H04)
PREZATIDE COPPER (UNII: 6BJQ43T1I9)
TOCOPHEROL (UNII: R0ZB2556P8)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
HORSE CHESTNUT (UNII: 3C18L6RJAZ)
ASPALATHUS LINEARIS LEAF (UNII: H7UGK1GJCU)
SOY PROTEIN (UNII: R44IWB3RN5)
HYDROLYZED WHEAT PROTEIN (ENZYMATIC; 3000 MW) (UNII: J2S07SB0YL)
AMINO ACIDS, WHEAT (UNII: 0370GZL32F)
INOSITOL (UNII: 4L6452S749)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ACETYLCYSTEINE SODIUM (UNII: NRD80R06FB)
PROCYANIDIN A2 (UNII: UQN6668Q4R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
ALCOHOL (UNII: 3K9958V90M)
CALCIUM PANTOTHENATE (UNII: 568ET80C3D)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
POLYOXYL 35 CASTOR OIL (UNII: 6D4M1DAL6O)
POLYQUATERNIUM-10 (20000 MPA.S AT 2%) (UNII: N2GK4S7X4T)
TAURINE (UNII: 1EQV5MLY3D)
EDETATE SODIUM (UNII: MP1J8420LU)
ETHYLBISIMINOMETHYLGUAIACOL MANGANESE CHLORIDE (UNII: SM5YJ88LTU)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69188-400-07	210 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/22/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Export only		01/22/2015

Labeler - DS Healthcare Group (015504134)

Establishment
Name	Address	ID/FEI	Business Operations
A.I.G. TECHNOLOGIES, INC.		086365223	manufacture(69188-400)