FDA.reportPublic FDA data

Active Ingredient(s)

Manufacturer
Shantou Ouhoe Technology Co., Ltd.
Effective date
2026-08-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-08-28 00:02:07

Label at a glance#

ProductHair Regrowth Foam
Active ingredientMINOXIDIL, BIOTIN
Label structure12 sections

Storage and handling

Store in a cool and dry place.

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

MINOXIDIL、BIOTIN

Purpose

OTC - PURPOSE SECTION

1、Reduces Hair Loss
2、Reactivates Hair Follicles
3、Improves Scalp Health

Use

OTC - WHEN USING SECTION

1.Cleanse and dry your scalp.

2.Press 1-2 pumps of foam and apply to the scalp.

3.Gently massage the scalp with your fingertips until absorbed.

Warnings

WARNINGS SECTION

Please keep out of reach of children. Do not swallow.Please clean your hands before use to ensure the best results from the product. Discontinue use if signs of irritation or rash occur. Store in a cool and dry place.

Do not use

OTC - DO NOT USE SECTION

Discontinue use if signs of irritation or rash occur.

STOP USE

OTC - STOP USE SECTION

Discontinue use if signs of irritation or rash occur.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Please keep out of reach of children. Do not swallow.

STORAGE AND HANDLING SECTION

Store in a cool and dry place.

INACTIVE INGREDIENT SECTION

AQUA、SODIUM LAURETH SULFATE、COCAMIDOPROPYL BETAINE、GLYCERIN、COCAMIDE DEA、1,2‑HEXANEDIOL、DISODIUM EDTA

DOSAGE & ADMINISTRATION SECTION

1.Cleanse and dry your scalp. 2.Press 1-2 pumps of foam and apply to the scalp. 3.Gently massage the scalp with your fingertips until absorbed.

INDICATIONS & USAGE SECTION

1.Cleanse and dry your scalp. 2.Press 1-2 pumps of foam and apply to the scalp. 3.Gently massage the scalp with your fingertips until absorbed.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85163-02185163-021-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
MINOXIDIL5965120SH1ACTIB
BIOTIN6SO6U10H04ACTIB
AQUA059QF0KO0RIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
GLYCERINPDC6A3C0OXIACT
COCAMIDE DEA92005F972DIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
EDETATE DISODIUM7FLD91C86KIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hair Regrowth FoamGLYCERINShantou Ouhoe Technology Co., Ltd.59ef5953-e96f-5707-e063-6294a90a30942026-08-26WarningsExact identifier
ndc (package): 85163-021-01
ndc (product): 85163-021
ndc11 (package): 85163002101
spl id: 59ef5953-e970-5707-e063-6294a90a3094
spl set id: 59ef5953-e96f-5707-e063-6294a90a3094

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.