NDC | 69188-163-60 |
Set ID | 52799309-5652-5ed7-e054-00144ff88e88 |
Category | HUMAN OTC DRUG LABEL |
Packager | DS Healthcare Group Inc. |
Generic Name | |
Product Class | 5-alpha Reductase Inhibitor, Arteriolar Vasodilator |
Product Number | |
Application Number |
- DOSAGE & ADMINISTRATION
-
WARNINGS
FOR EXTERNAL USE ONLY. AVOID CONTACT WITH EYES. NOT FOR WOMEN. DO NOT
USE THIS PRODUCT IF YOU HAVE HEART DISEASE OR ARE TAKING BLOOD-PRESSURE-LOWERING
MEDICATIONS. DISCONTINUE USE IMMEDIATELY AND SEE A PHYSICIAN IF YOU EXPERIENCE
CHEST PAIN OR RAPID HEARTBEAT. DO NOT USE IF YOU ARE UNDER 18 YEARS OF AGE. KEEP
OUT OF REACH OF CHILDREN. -
INACTIVE INGREDIENT
DEIONIZED WATER, PROPYLENE GLYCOL, ETHYL ALCOHOL, LACTIC ACID, PANTHENYL ETHYL
ETHER, INOSITOL, ACETYL METHIONINE, MILK PROTEIN, SODIUM CITRATE, ACETYL CYSTEINE,
LACTOSE, CITRIC ACID, PHOSPHOLIPIDS, RETINOL, GLYCERIN, POLYSORBATE 80, MYRISTOYL
PENTAPEPTIDE-17, COPPER TRIPEPTIDE-1, PHENOXYETHANOL, CAPRYLYL GLYCOL - INDICATIONS & USAGE
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- ACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
NR-11
minoxidil sulfate, finasteride, alfatradiol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69188-163 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALFATRADIOL (UNII: 3VQ38D63M7) (ALFATRADIOL - UNII:3VQ38D63M7) ALFATRADIOL 0.05 g in 100 g MINOXIDIL SULFATE ESTER (UNII: 2H6K6Y231J) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL SULFATE ESTER 12 g in 100 g FINASTERIDE (UNII: 57GNO57U7G) (FINASTERIDE - UNII:57GNO57U7G) FINASTERIDE 0.01 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) CASEIN (UNII: 48268V50D5) LACTOSE (UNII: J2B2A4N98G) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) INOSITOL (UNII: 4L6452S749) ACETYLCYSTEINE (UNII: WYQ7N0BPYC) SODIUM CITRATE (UNII: 1Q73Q2JULR) GLYCERIN (UNII: PDC6A3C0OX) POLYSORBATE 80 (UNII: 6OZP39ZG8H) MYRISTOYL PENTAPEPTIDE-4 (UNII: PMA59A699X) PREZATIDE COPPER (UNII: 6BJQ43T1I9) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ALCOHOL (UNII: 3K9958V90M) LACTIC ACID (UNII: 33X04XA5AT) PANTHENYL ETHYL ETHER (UNII: F4WMF8NX3B) N-ACETYLMETHIONINE (UNII: 9J12WX5B6A) RETINOL (UNII: G2SH0XKK91) Product Characteristics Color yellow (Light yellow thin liquid) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69188-163-60 60 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 06/21/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Export only 06/21/2017 Labeler - DS Healthcare Group Inc. (015504134) Registrant - DS Healthcare Group Inc. (015504134) Establishment Name Address ID/FEI Business Operations DS Healthcare Group Inc. 015504134 relabel(69188-163) Establishment Name Address ID/FEI Business Operations A.I.G. Technologies Inc. 171837367 manufacture(69188-163)