OLIVITA 5% MINOXIDIL- 5% minoxidil solution

OLIVITA 5% Minoxidil by

Drug Labeling and Warnings

OLIVITA 5% Minoxidil by is a Otc medication manufactured, distributed, or labeled by Shenzhen Xinxin Yunhai Technology Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Minoxidil 5.0% w/v

Purpose

Hair regrowth treatment for men

Use

to regrow hair on the top of the scalp (vertex only, see picture on side of box)

Warnings

For external use only. For use by men only.
Flammable: Keep away from fire or flame

Do not use

▪ you are a woman
▪ your amount of hair loss is different than that shown on the side of this box or your hair loss is on the front of the scalp. 5% Minoxidil Topical Solution is not intended for frontal baldness or receding hairline.
▪ you have no family history of hair loss
▪ your hair loss is sudden and/or patchy
▪ you do not know the reason for your hair loss
▪ you are under 18 years of age. Do not use on babies and children.
▪ your scalp is red, inflamed, infected, irritated, or painful
▪ you use other medications on the scalp

When Using

▪ do not apply on other parts of the body
▪ avoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water.
▪ some people have experienced changes in hair color and/or texture
▪ it takes time to regrow hair. Results may occur at 2 months with twice a day usage. For some men, you may need to use this product for at least 4 months before seeing results.
▪ the amount of hair regrowth is different for each person. This product will not work for all men.

Stop Use

▪ chest pain, rapid heartbeat, faintness, or dizziness occurs
▪ sudden, unexplained weight gain occurs
▪ your hands or feet swell
▪ scalp irritation or redness occurs
▪ unwanted facial hair growth occurs
▪ you do not see hair regrowth in 4 months

Ask Doctor

▪ chest pain, rapid heartbeat, faintness, or dizziness occurs
▪ sudden, unexplained weight gain occurs
▪ your hands or feet swell
▪ scalp irritation or redness occurs
▪ unwanted facial hair growth occurs
▪ you do not see hair regrowth in 4 months
May be harmful if used when pregnant or breastfeeding.

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

▪ apply one ml. (6 sprays) 2 times a day directly onto the scalp in the hair loss area
▪ 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

Other information

▪ see hair loss pictures on side of this box
▪ before use, read all information on carton and enclosed insert
▪ keep carton, it contains important information
▪ hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with Minoxidil Topical Solution 5% for men
▪ in clinical studies with mostly white men aged 18-49 years with moderate degrees of hair loss, Minoxidil Topical Solution 5% for men provided more hair regrowth than Minoxidil Topical Solution 2%
▪ store at controlled room temperature 20° to 25°C (68° to 77°F)

Inactive ingredients

alcohol, propylene glycol, purified water

Questions

Email: support@olivitabeauty.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

OLIVITA 5% MINOXIDIL 
5% minoxidil solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83818-028
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
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83818-028-01	2 in 1 BOX	02/15/2026
1		60 mL in 1 BOTTLE; 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	02/15/2026

Labeler - Shenzhen Xinxin Yunhai Technology Co., Ltd. (699816806)

Establishment
Name	Address	ID/FEI	Business Operations
Shenzhen Xinxin Yunhai Technology Co., Ltd.		699816806	manufacture(83818-028)