ANAGEN TOPICAL SOLUTION- ru-58841 5% solution

Anagen Topical Solution by

Drug Labeling and Warnings

Anagen Topical Solution by is a Otc medication manufactured, distributed, or labeled by ANAGEN INNOVATION MEDICINE LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ru-58841 5%

PURPOSE

Hair Regrowth Treatment

INDICATIONS & USAGE

Hair Regrowth Treatment
For Research Purpose OnlyNot For Human Consumption

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN SECTION

WARNINGS

For external use only

DOSAGE & ADMINISTRATION

Take an appropriate amount of solution and apply it to the root of the head

INACTIVE INGREDIENT

GLYCERIN
ALCOHOL
LEVOMENTHOL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANAGEN TOPICAL SOLUTION 
ru-58841 5% solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85475-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
RU-58841 (UNII: 0D8FJQ0ADW) (RU-58841 - UNII:0D8FJQ0ADW)	RU-58841	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
LACTIC ACID (UNII: 33X04XA5AT)
WATER (UNII: 059QF0KO0R)
MENTHOL (UNII: L7T10EIP3A)
GLYCERIN (UNII: PDC6A3C0OX)
ALCOHOL (UNII: 3K9958V90M)
CITRIC ACID (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85475-001-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/03/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	04/03/2025

Labeler - ANAGEN INNOVATION MEDICINE LTD (232423099)

Establishment
Name	Address	ID/FEI	Business Operations
ANAGEN INNOVATION MEDICINE LTD		232423099	manufacture(85475-001)