MedPath

HAIR GROWTH FOAM

83804-008 HAIR GROWTH FOAM

Approved
Approval ID

3ceecb17-b013-f957-e063-6394a90ae2ed

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 22, 2025

Manufacturers
FDA

Shenzhen Shandian Jingling Technology Co., Ltd.

DUNS: 418636058

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

MINOXIDIL

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code83804-008
Application Number505G(a)(3)
Product Classification
M
Marketing Category
C200263
G
Generic Name
MINOXIDIL
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 22, 2025
FDA Product Classification

INGREDIENTS (21)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
1-BUTENEInactive
Code: LY001N554L
Classification: IACT
NIACINAMIDEInactive
Code: 25X51I8RD4
Classification: IACT
REYNOUTRIA MULTIFLORA WHOLEInactive
Code: 85S46HFR8A
Classification: IACT
CAFFEINEInactive
Code: 3G6A5W338E
Classification: IACT
SODIUM COCOYL GLYCINATEInactive
Code: XLU9KH03XM
Classification: IACT
DIETHYL ETHANOLAMINEInactive
Code: S6DL4M053U
Classification: IACT
PLATYCLADUS ORIENTALIS WHOLEInactive
Code: 835370K47L
Classification: IACT
BISPHENOL AInactive
Code: MLT3645I99
Classification: IACT
BIOTINInactive
Code: 6SO6U10H04
Classification: IACT
SODIUM HYALURONATEInactive
Code: YSE9PPT4TH
Classification: IACT
HYDROXYACETOPHENONEInactive
Code: G1L3HT4CMH
Classification: IACT
ZANTHOXYLUM BUNGEANUM FRUITInactive
Code: 3CIP16A418
Classification: IACT
LIGUSTRUM LUCIDUM FRUITInactive
Code: M9G2U96DUT
Classification: IACT
MINOXIDILActive
Quantity: 5 g in 100 mL
Code: 5965120SH1
Classification: ACTIB
GLYCOLInactive
Code: FC72KVT52F
Classification: IACT
LIGUSTICUM WALLICHII ROOTInactive
Code: R81AD159QS
Classification: IACT
3-O-ETHYL ASCORBIC ACIDInactive
Code: 6MW60CB71P
Classification: IACT
PANTHENOLInactive
Code: WV9CM0O67Z
Classification: IACT
ROSA CANINA FRUIT OILInactive
Code: CR7307M3QZ
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/27/2025

label

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/27/2025

to regrow hair on the top of the scalp

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/27/2025

water
minoxidil
glycerin
butylene
glycol
niacinamide
capilia longa biota orientalis leaf extract
polygonum multiflorumextract
ligustrum lucidum fruit
extractligusticum chuanxiong root
extract zanthoxylum bungeanum
fruit extract 3-o-ethylascorbic acid
rosa canina fruit oil
sodium cocoyl glycinate
biotin
panthenol
caffeine
sodium hyaluronate
diso-dium edta
hydroxyacetophenone
1.2-nexanedi0l

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/27/2025

MINOXIDIL 5%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/27/2025

Hair Regrowth Treatment

WARNINGS SECTION

LOINC: 34071-1Updated: 8/27/2025

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

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 8/27/2025

you have no family history of hair loss
your hair loss is sudden and/or patchy
you do not know the reason for yourhair loss
you are under 18 years of age. Do notuse on babies and children
your scalp is red, inflamed, infectedirritated or painful
you use other medicines on the scalp

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 8/27/2025

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 chan-ges in hair color and/or texture
it takes time to regrow hair. Results may occur at 2 months with twice a day us-age. For some men, you may need to use this product for at least 4 months before you see results

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 8/27/2025

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 8/27/2025

If swallowed,get medical help or con-tact a Poison Control Center right away.(1-800-222-1222)

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/27/2025

apply one mL with dropper 2 times a day directly onto the scalp in the hair loss area
using more or more often will not im-prove results
continued use is necessary to incre-ase and keep your hair regrowth, or hair loss will begin again

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