DR MANALI HAIR SERUM FOR MEN- minoxidil 5% liquid

Dr manali hair serum for men by

Drug Labeling and Warnings

Dr manali hair serum for men by is a Otc medication manufactured, distributed, or labeled by Dr Manali Products. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingridient : minoxidil USP 5%

PURPOSE

Hair Growth

INDICATIONS & USAGE

Uses: to regrow hair on the top of the scalp

WARNINGS

Warnings: For eldemal use only. For use by men only. Flarnmabk!: Keep away from fire or flame

Warnings: Do not use 11:■You are a woman ■ You have no family histcxy of hair loss ■ Your hair loss is sudden or patchy ■ You do not know the reason for your hair loss ■You do not know the reason for your hair loss you are under 18 years of age.■ Do not use on babies or children ■Your scalp is red, inflamed, infected, irritated, or painful ■ You use other medications on the scalp

Ask a doctor before use if you have heart disease.

WHEN USING

When using this product: ■ Do not apply on other areas of the body ■ Avoid contact with eyes. In case of contact rinse eyes wnh large announts of cool tap water ■ It takes time to regrow hair. Results may occur at 2 months 􀁒h twice daily usage. For some men you may need to use this product for at least

4 months before you see results ■The annount of hair regrowth is different for each person. This product will not work for all men.

DO NOT USE

Do not use if :■You are a woman ■ You have no family history of hair loss ■ Your hair loss is sudden or patchy ■ You do not know the reason for your hair loss ■You do not know the reason for your hair loss you are under 18 years of age.■ Do not use on babies or children ■Your scalp is red, inflamed, infected, irritated, or painful ■ You use other medications on the scalp

ASK DOCTOR

Ask a doctor before use if you have heart disease.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222)

DOSAGE & ADMINISTRATION

Apply 1 ml with dropper 2 times a day directly onto scalp in the area of hair loss ■ Using more or more often will not improve results ■ Continued use is necessary to increase and keep your hair ■ Regrowth, or hair loss will begin again

STORAGE AND HANDLING

Store at room temperature 68 to 77 F (or 20 to 25 C), in a dry place. Keep tightly closed..

INACTIVE INGREDIENT

Inactive Ingredients: Biotin Liposomes (water, alcohol, panthenol, lecithin, tocopheryl acetate, caffeine, biotin), Ethyl Alcohol, Dimethyl lsosorbide, Melatonin, Prickly Pear Extract (glycerin & water & Opuntia Tuna Flower/Stem Extract), Propylene Glycol, Red Clover Extract (Certified Organic Red Clover (Trifolium Pratense) dried Leal, vegetable glycerin, alcohol, water], Saw Palmetto/Serenoa repens Extract (glycerin, water, Serenoa Serrulata Fruit Extract, Maltodextrin), Vitamin A Liposomes (lecithin, retinal, polysorbate 20)

QUESTIONS

Questions and Comments? Call1 30111116 8333

Monday through Friday 9:00 AM -4:00 PM EST

Email us at info@drmanaliproducts.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DR MANALI HAIR SERUM FOR MEN 
minoxidil 5% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83361-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1)	MINOXIDIL	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
MELATONIN (UNII: JL5DK93RCL)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
ALCOHOL (UNII: 3K9958V90M)
PANTHENOL (UNII: WV9CM0O67Z)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
BIOTIN (UNII: 6SO6U10H04)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
VITAMIN A (UNII: 81G40H8B0T)
PRICKLY PEAR FRUIT (UNII: 18V8PAQ629)
RED CLOVER (UNII: L9153EKV2Y)
TRIFOLIUM PRATENSE LEAF (UNII: 612YOZ36DG)
WATER (UNII: 059QF0KO0R)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
GLYCERIN (UNII: PDC6A3C0OX)
SAW PALMETTO (UNII: J7WWH9M8QS)
CAFFEINE (UNII: 3G6A5W338E)
OPUNTIA TUNA STEM (UNII: 2HCC68I98K)
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)
RETINOL (UNII: G2SH0XKK91)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83361-002-02	1 in 1 CARTON	02/01/2024
1	NDC: 83361-002-01	60 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M032	02/01/2024

Labeler - Dr Manali Products (110035406)

Establishment
Name	Address	ID/FEI	Business Operations
Dr Manali Products		110035406	manufacture(83361-002)