85407-001

85407-001
SPL v2
SPL
SPL Set ID 30d0e538-963e-2aa5-e063-6394a90ae742
Route
TOPICAL
Published
Effective Date 2025-03-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (5 g)
Inactive Ingredients
Mung Bean Water Butanediol (mixed Isomers) Platycladus Orientalis Leaf Ginger Rhein Tobacco Leaf Lemon Orange Terpenes Curcumin Red Clover Phenoxyethanol

Identifiers & Packaging

Marketing Status
ANDA Active Since 2025-03-21

Description

minoxidil 5%

Purpose

Hair Begrowth Treatment


Medication Information

Purpose

Hair Begrowth Treatment

Description

minoxidil 5%

Use

To regrow hair on the top of the scalp



Section 50565-1

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



Section 50566-9

Stop use and ask a doctor iritation 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

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

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



Warnings

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



Directions

1. Massage the scalp to completely relax the scalp.

2. Apply one or two drops to the scalp area to be used.

3. Apply evenly to the rest of the area.

4. Use twice a day.



Do Not Use

●in children less than 2 months of age

●on open skin wounds

Other Information

Store at controlled room temperature 20° to25°C (68° to 77*F).



Active Ingredient(s)

minoxidil 5%

Inactive Ingredients

Water, Butanediol,Platycladus orientalis leaf extract,Ginger root extract, Polygonum

multiflorum extract, Tobacco extract,lemon extract,Sweet orange extract, Turmeric

extract,vigna radiata,red clover phenoxyaethanolum



Package Label Principal Display Panel


Structured Label Content

Use

To regrow hair on the top of the scalp



Section 50565-1 (50565-1)

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



Section 50566-9 (50566-9)

Stop use and ask a doctor iritation 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

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

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



Purpose

Hair Begrowth Treatment

Warnings

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



Directions

1. Massage the scalp to completely relax the scalp.

2. Apply one or two drops to the scalp area to be used.

3. Apply evenly to the rest of the area.

4. Use twice a day.



Do Not Use (Do not use)

●in children less than 2 months of age

●on open skin wounds

Other Information (Other information)

Store at controlled room temperature 20° to25°C (68° to 77*F).



Active Ingredient(s)

minoxidil 5%

Inactive Ingredients (Inactive ingredients)

Water, Butanediol,Platycladus orientalis leaf extract,Ginger root extract, Polygonum

multiflorum extract, Tobacco extract,lemon extract,Sweet orange extract, Turmeric

extract,vigna radiata,red clover phenoxyaethanolum



Package Label Principal Display Panel (Package Label - Principal Display Panel)


Advanced Ingredient Data


Raw Label Data

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