5% MINOXIDIL HAIR GROWTH FOAM WITH BIOTIN- minoxidil aerosol, foam

5% Minoxidil Hair Growth Foam with Biotin by

Drug Labeling and Warnings

5% Minoxidil Hair Growth Foam with Biotin by is a Otc medication manufactured, distributed, or labeled by Shenzhen Ctrip Technology Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

5% Minoxidil Hair Growth Foam with Biotin

ACTIVE INGREDIENT

Minoxidil 5%
Biotin 0.5%

PURPOSE

Hair Regrowih Treaiment

INDICATIONS & USAGE

Use to regrow hair of the scalp

WARNINGS

Flammable:keep away from fire or flame.
Keep out of reach of children.
For exlernal use oniy

DO NOT USE

Your hair loss is gudden andlor palchy.
Your hair loss is associald with chidbinth.
You do nol knaw the reason for your hair logs.
You are under 18 years of age. Do not use on babies and children.
Your gcalp is red, intamed, infecled, irritated, or painfu.
You use other medicines on the scalp.

WHEN USING

Awoid contact with the eyes. in case of accidenlal conlact, rinse eyes withlarge amcunts of cool tap waler.
Some people have experienced changes in hair color andlor lexture.
It takes time lo regrow hair, Resuts may ooour at 3 monihs with twice a dayusage. For some men, you may need to use this product for at least 6 monlhsbefore you see results. The amount of hair regrowih is diferent for eachpergon.
Awoid contact with eyes. in case of aocidenlal contact, rinse eyes with alarge amcunt of cool tap waler.

STOP USE

Chest pain, rapid hearibeat, aininegs, or dizziness oocurs.
Sudden, unexplained weight gain oocurs.
If umwaneed facil har growth occurs .
lf you do nat see hair regrowth in 6 months.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.lf swalkwed, get medical help or contac a Poison Conlrol Cenler(1-800-222-1222) right away.

DOSAGE & ADMINISTRATION

1.Shake the bollle, hold it upside down and genlly press the walve to dispensefoam onio your hand, approximalely the size of half a capful
2.Massage the foam inio your gcalp with your fngers, paring your hair intorows to ensure even application to areas with thinning hair. Then, wash yourhands thoroughly.
3.Use Twice Daily and enjoy thicker, fuler hair gronth in as lille as 3 to 6months.

STORAGE AND HANDLING

Before use, read al informglion on carton and enclosed leale.Store at conlrolled room temperalure 20° lo 25°℃ (68° to 77°F)Do not incinerale container. Do not expose to heat or slore at lemperalureabove 104° F(40°C).

INACTIVE INGREDIENT

ALCOHOL
GLYCERIN
CETYL ALCOHOL
STEARYL ALCOHOL
POLYSORBATE 80
ANHYDROUS CITRIC ACID
LACTIC ACID
CASTOR OIL
.ALPHA.-TOCOPHEROL
EDETATE DISODIUM
ISOBUTANE
BUTANE
WATER

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

5% MINOXIDIL HAIR GROWTH FOAM WITH BIOTIN 
minoxidil aerosol, foam

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84614-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04)	BIOTIN	0.5 g  in 100 g
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1)	MINOXIDIL	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
BUTANE (UNII: 6LV4FOR43R)
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
LACTIC ACID (UNII: 33X04XA5AT)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERIN (UNII: PDC6A3C0OX)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
ISOBUTANE (UNII: BXR49TP611)
CASTOR OIL (UNII: D5340Y2I9G)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84614-003-01	2 in 1 PACKAGE	09/10/2024
1		60 g in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 84614-003-02	3 in 1 PACKAGE	09/10/2024
2		60 g 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	505G(a)(3)	09/10/2024

Labeler - Shenzhen Ctrip Technology Co., Ltd. (403113060)

Establishment
Name	Address	ID/FEI	Business Operations
Shenzhen Ctrip Technology Co., Ltd.		403113060	manufacture(84614-003)