81653-001 Update

81653-001 Update
SPL v5
SPL
SPL Set ID bcafff1c-26c8-57c8-e053-2a95a90ad5f0
Route
TOPICAL
Published
Effective Date 2021-03-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (5 g)
Inactive Ingredients
Capsaicin Platycladus Orientalis Seed Water Alcohol Ginger Ligusticum Sinense Subsp. Chuanxiong Root Glycyrrhiza Uralensis Root Reynoutria Multiflora Root Fraxinus Excelsior Bark Arctium Lappa Whole Angelica Sinensis Root Biotin Asian Ginseng Safflower

Identifiers & Packaging

Marketing Status
ANDA Active Since 2021-03-05

Description

Minoxidil


Medication Information

Warnings and Precautions

For adult external use only. Flammable. Keep away from heat or flame

Description

Minoxidil

Use[s]

Hair growth serum to help firming hair root and balancing the head skin secretion, improve thescalp itching, remove the grease, clear the hair follicles to promote the hair growth, reduce the hair loss and broken hair, give you a healthy hair looks.

Section 50565-1

Keep out of reach of children.lf swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Section 50567-7

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Section 50570-1

Pregnant women and children.

on open skin wounds

Section 51727-6

water, alcohol, Ginseng Extract, Ginger Extract, CARTHAMUS TINCTORIUS (SAFFLOWER) FLOWER EXTRACT, FRAXINUS EXCELSIOR BARK EXTRACT, FRUCTUS ACEROLA EXTRACT, LIGUSTICUM CHUANXIONG ROOT EXTRACT, GLYCYRRHIZA URALENSIS (LICORICE) ROOT EXTRACT, Arctium Lappa L., ANGELICA SINENSIS ROOT EXTRACT, THUJA ORIENTALIS SEED EXTRACT, POLYGONUM MULTIFLORUM ROOT EXTRACT, Capsaicin, Vitamin H (Biotin)

Section 51945-4

Section 55105-1

Promotes hair growth

Section 55106-9

Minoxidil

Directions

Put right amount of hair growth serum apply on the hairloss area or hair scalp, gentle to massage to help absort.

1-2 times per day.

Other Information

Store between 15-30°C (59-86°F)

Avoid freezing and excessive heat above 40°C (104°F)


Structured Label Content

Use[s]

Hair growth serum to help firming hair root and balancing the head skin secretion, improve thescalp itching, remove the grease, clear the hair follicles to promote the hair growth, reduce the hair loss and broken hair, give you a healthy hair looks.

Warnings and Precautions (34071-1)

For adult external use only. Flammable. Keep away from heat or flame

Section 50565-1 (50565-1)

Keep out of reach of children.lf swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Section 50567-7 (50567-7)

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Section 50570-1 (50570-1)

Pregnant women and children.

on open skin wounds

Section 51727-6 (51727-6)

water, alcohol, Ginseng Extract, Ginger Extract, CARTHAMUS TINCTORIUS (SAFFLOWER) FLOWER EXTRACT, FRAXINUS EXCELSIOR BARK EXTRACT, FRUCTUS ACEROLA EXTRACT, LIGUSTICUM CHUANXIONG ROOT EXTRACT, GLYCYRRHIZA URALENSIS (LICORICE) ROOT EXTRACT, Arctium Lappa L., ANGELICA SINENSIS ROOT EXTRACT, THUJA ORIENTALIS SEED EXTRACT, POLYGONUM MULTIFLORUM ROOT EXTRACT, Capsaicin, Vitamin H (Biotin)

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Promotes hair growth

Section 55106-9 (55106-9)

Minoxidil

Directions

Put right amount of hair growth serum apply on the hairloss area or hair scalp, gentle to massage to help absort.

1-2 times per day.

Other Information (Other information)

Store between 15-30°C (59-86°F)

Avoid freezing and excessive heat above 40°C (104°F)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)