MINOXIDIL TOPICAL liquid

MINOXIDIL TOPICAL by

Drug Labeling and Warnings

MINOXIDIL TOPICAL by is a Otc medication manufactured, distributed, or labeled by Wenchang Panzhijie Trading Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Minoxidil 5%

Purpose

Hair Regrowth Treatment

Use

to regrow hair on the top of the scalp

Warnings

For external use only

Keep away from fire and flame

Avoid contact with eyes

Do not use

You have no family history of hair loss. 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 it onbabies and children.Scalp is red, inflamed, infected, irritated or painful.

You use other medicines on the scalp.

STOP USE AND SEE A DOCTOR

If scalp irritation or redness occurs.

If you get unwanted facial hair growth.

If you do not see hair regrowth in 4 months.

If sudden, unexplained weight gain occurs.

KEEP OUT OF REACH OF CHILDREN

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

Directions

Apply 1ml(5 Sprays) twice a day.Once in the morning and another time in the evening before bed.

Spray directly on top of the scalp in the area to be treated.

Discontinuing use may result in hair loss.

Inactive ingredients

WATER, PROPYLENE GLYCOL, GLYCERIN, ZINGIBER OFFICINALE(GINGER)ROOT EXTRACT, PEG-40 HYDROGENATED CASTOR OIL, PANAX GINSENG EXTRACT, BIOTIN, XANTHAN GUM, RICINUS COMMUNIS(CASTOR)OIL, ROSMARINUS OFFICINALIS(ROSEMARY)LEAF OIL.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MINOXIDIL TOPICAL 
minoxidil topical liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83717-004
Route of Administration	CUTANEOUS

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
ROSEMARY OIL (UNII: 8LGU7VM393)
GINGER (UNII: C5529G5JPQ)
ASIAN GINSENG (UNII: CUQ3A77YXI)
CASTOR OIL (UNII: D5340Y2I9G)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
BIOTIN (UNII: 6SO6U10H04)
XANTHAN GUM (UNII: TTV12P4NEE)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83717-004-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/24/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA209074	08/24/2024

Labeler - Wenchang Panzhijie Trading Co., Ltd. (699321271)

Establishment
Name	Address	ID/FEI	Business Operations
Wenchang Panzhijie Trading Co., Ltd.		699321271	manufacture(83717-004)