Minoxidil Spray

Minoxidil Spray
SPL v4
SPL
SPL Set ID 03738dd6-a42c-0986-e063-6294a90a1cc0
Route
TOPICAL
Published
Effective Date 2024-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (5 g)
Inactive Ingredients
Alcohol Water Propylene Glycol

Identifiers & Packaging

Marketing Status
ANDA Active Since 2024-01-01

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

For external use only. For use by men only.

Flammable: Keep away from fire or flame

Indications and Usage

1 Bottle Carton

Use to regrow hair on the scalp (vertex only, see picture on side of carton)

3 Bottle Carton

Use to regrow hair on the scalp (vertex only, see picture on side of carton)

Dosage and Administration

Directions

Prime the sprayer by holding the bottle the bottle upright and pump the sprayer 5 times to ensure delivery of full spray. Do not inhale mist

Apply one mL with spray (6 sprays) 2 times a day directly onto the scalp in the hair loss area

Using more or more often will not improve restuls

Continued use is necessary to increase and keep your hair regrowth, or hair loss will begind again.

Description

Drug Facts

Section 42229-5

Drug Facts

Section 51727-6

Inactive ingredients Alcohol, propylene glycol, purified water

Section 53413-1
Questions? 1-424-347-6299 Visit website at ro.co

Section 55105-1

1 Bottle Carton

Purpose

Hair regrowth treatment for men

3 Bottle Carton

Purpose

Hair regrowth treatment

Section 55106-9

1 Bottle Carton

Active Ingredient

Minoxidil, USP 5% w/v

3 Bottle Carton

Active Ingredient

Minoxidil 5% w/v

Section 60561-8

Other information

See hair loss pictures on side of this carton

Before use, read all information on carton and enclosed leaflet

Hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with 5% minoxidil topical solution for men

Keep the carton. It contains important information.

In clinical studies of mostly white men aged 18-45 years with moderate degrees of hairloss, 5% minoxidil topical solution for men provided more hair regrowth than 2% minoxidil topical solution

Store at controlled room temperature 20 to 25C (68 to 77F)

Three Bottle Package

NDC xxxxx-xxx-xx

roman

HAIR

REGROWTH

TREATMENT

5% Minoxidil Topical Solution, USP

Extra Strength formula for men

Clinically proven to help regrow hair

Reactivates hair follicles to stimulate growth

Easy precision sprayer

Unscented topical solution

Three month supply

3- 60 mL (2 fl oz) bottles

Total 180 mL (6 fl oz)

Not for use by women

Single Bottle Package

NDC XXXXX-XXX-XX

roman

Hair Regrowth Treatment

5% Minoxidil Topical Solution, USP

Extra Strength formula for men

Clinically proven to help regrow hair

Reactivates hair follicales to stimulate regrowth

Easy precision sprayer

Unscented topical solution

One month supply

1 - 60 mL (2 fl oz) bottle

Not for use by women.


Structured Label Content

Indications and Usage (34067-9)

1 Bottle Carton

Use to regrow hair on the scalp (vertex only, see picture on side of carton)

3 Bottle Carton

Use to regrow hair on the scalp (vertex only, see picture on side of carton)

Dosage and Administration (34068-7)

Directions

Prime the sprayer by holding the bottle the bottle upright and pump the sprayer 5 times to ensure delivery of full spray. Do not inhale mist

Apply one mL with spray (6 sprays) 2 times a day directly onto the scalp in the hair loss area

Using more or more often will not improve restuls

Continued use is necessary to increase and keep your hair regrowth, or hair loss will begind again.

Warnings and Precautions (34071-1)

Warnings

For external use only. For use by men only.

Flammable: Keep away from fire or flame

Section 42229-5 (42229-5)

Drug Facts

Section 51727-6 (51727-6)

Inactive ingredients Alcohol, propylene glycol, purified water

Section 53413-1 (53413-1)
Questions? 1-424-347-6299 Visit website at ro.co

Section 55105-1 (55105-1)

1 Bottle Carton

Purpose

Hair regrowth treatment for men

3 Bottle Carton

Purpose

Hair regrowth treatment

Section 55106-9 (55106-9)

1 Bottle Carton

Active Ingredient

Minoxidil, USP 5% w/v

3 Bottle Carton

Active Ingredient

Minoxidil 5% w/v

Section 60561-8 (60561-8)

Other information

See hair loss pictures on side of this carton

Before use, read all information on carton and enclosed leaflet

Hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with 5% minoxidil topical solution for men

Keep the carton. It contains important information.

In clinical studies of mostly white men aged 18-45 years with moderate degrees of hairloss, 5% minoxidil topical solution for men provided more hair regrowth than 2% minoxidil topical solution

Store at controlled room temperature 20 to 25C (68 to 77F)

Three Bottle Package

NDC xxxxx-xxx-xx

roman

HAIR

REGROWTH

TREATMENT

5% Minoxidil Topical Solution, USP

Extra Strength formula for men

Clinically proven to help regrow hair

Reactivates hair follicles to stimulate growth

Easy precision sprayer

Unscented topical solution

Three month supply

3- 60 mL (2 fl oz) bottles

Total 180 mL (6 fl oz)

Not for use by women

Single Bottle Package

NDC XXXXX-XXX-XX

roman

Hair Regrowth Treatment

5% Minoxidil Topical Solution, USP

Extra Strength formula for men

Clinically proven to help regrow hair

Reactivates hair follicales to stimulate regrowth

Easy precision sprayer

Unscented topical solution

One month supply

1 - 60 mL (2 fl oz) bottle

Not for use by women.


Advanced Ingredient Data


Raw Label Data

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