83788-301

83788-301
SPL v1
SPL
SPL Set ID 188dd4b9-6cd1-262c-e063-6394a90a6d93
Route
TOPICAL
Published
Effective Date 2024-05-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (5 g)
Inactive Ingredients
Panax Notoginseng Root Ricinus Communis Leaf Water Xanthan Gum Propylene Glycol Biotin Ginger Castor Oil Glycerin Ethylhexylglycerin Rosemary Oil Phenoxyethanol Polyoxyl 40 Castor Oil

Identifiers & Packaging

Marketing Status
ANDA Active Since 2024-05-16

Description

Minoxidil 5%

Purpose

HAIR REGROWTH


Medication Information

Purpose

HAIR REGROWTH

Description

Minoxidil 5%

Use

Helps the growth of hair follicles

and strengthens hair roots

Stop Use

Pregnant.Feeding.Having heartsensibilily.Super-sensitive skin.Havingopenwounds Planning to do physicalactivitiesin thenext hour.

Warnings

Only for external use.

Ask Doctor

use and ask adoctor if irritation orrash occurs Keep out of reach of children. lfswallowed, get medical help.

Directions

Press the spray on the product at acertain distance from the scalp andmassage gently until absorbed. Pleasewash your hands after

completion

Do Not Use

Pregnant.Feeding.Having heartsensibilty. Super-sensitive skin. Havingopen woundsPlanning to do physicalactivities in thenext hour.

When Using

When using this product keep out ofs,and mouth.In case ofeyesears,contact with eyes, rinse eves thoroughlywith waterStop use and ask a doctor if irritation orrash occursKeep ol of reach of children. lfswallowed, get medical help.

Active Ingredient

Minoxidil 5%

Other Information

Store between 15-30C(59-86F) Avoid freezing and excessive heat above 40C(104F)

Inactive Ingredients

Aqua, Propylene Glycol,Glycerin, ZingiberOfficinale (Ginger) RootExtract, PEG-40 HydrogenateCastor Oil, Panax GinsengExtract, Biotin, Xanthan Gum.Ricinus.Communis (Castor)Oil,Rosmarinus Officinalis(RoseMary) Leaf Oil,PhenoxyethaNol, Ethylhex-yl-Glycerin.

Principal Display Panel

Keep Oot of Reach of Children

When using this product keep out ofs,and mouth.In case ofeyes ears,contact with eyes, rinse eves thoroughlywith waterStop use and ask doctor if irritation orrash occursKeep ol of reach of children. lfswallowed, get medical help.


Structured Label Content

Use

Helps the growth of hair follicles

and strengthens hair roots

Purpose

HAIR REGROWTH

Stop Use

Pregnant.Feeding.Having heartsensibilily.Super-sensitive skin.Havingopenwounds Planning to do physicalactivitiesin thenext hour.

Warnings

Only for external use.

Ask Doctor

use and ask adoctor if irritation orrash occurs Keep out of reach of children. lfswallowed, get medical help.

Directions

Press the spray on the product at acertain distance from the scalp andmassage gently until absorbed. Pleasewash your hands after

completion

Do Not Use (Do not use)

Pregnant.Feeding.Having heartsensibilty. Super-sensitive skin. Havingopen woundsPlanning to do physicalactivities in thenext hour.

When Using

When using this product keep out ofs,and mouth.In case ofeyesears,contact with eyes, rinse eves thoroughlywith waterStop use and ask a doctor if irritation orrash occursKeep ol of reach of children. lfswallowed, get medical help.

Active Ingredient

Minoxidil 5%

Other Information (Other information)

Store between 15-30C(59-86F) Avoid freezing and excessive heat above 40C(104F)

Inactive Ingredients (Inactive ingredients)

Aqua, Propylene Glycol,Glycerin, ZingiberOfficinale (Ginger) RootExtract, PEG-40 HydrogenateCastor Oil, Panax GinsengExtract, Biotin, Xanthan Gum.Ricinus.Communis (Castor)Oil,Rosmarinus Officinalis(RoseMary) Leaf Oil,PhenoxyethaNol, Ethylhex-yl-Glycerin.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Oot of Reach of Children (Keep Oot Of Reach Of Children)

When using this product keep out ofs,and mouth.In case ofeyes ears,contact with eyes, rinse eves thoroughlywith waterStop use and ask doctor if irritation orrash occursKeep ol of reach of children. lfswallowed, get medical help.


Advanced Ingredient Data


Raw Label Data

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