SANTO REMEDIO WOMENS HAIR REGROWTH TREATMENT MINOXIDIL UNSCENTED- minoxidil solution

Santo Remedio Womens Hair Regrowth Treatment Minoxidil Unscented by

Drug Labeling and Warnings

Santo Remedio Womens Hair Regrowth Treatment Minoxidil Unscented by is a Otc medication manufactured, distributed, or labeled by SANTO REMEDIO LLC, Pure Source, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Minoxidil 2% w/v

Purpose

Hair regrowth treatment 

Use

to regrow hair on the scalp 

Warnings

For external use only. For use by men only.

Flammable:Keep away from fire or flame

Do not use If

• your amount of hair loss is different than that shown on the side of this carton, because this product may not work for you 
• you have no family history of hair loss 
• your hair loss is sudden and/or patchy 
• your hair loss is associated with childbirth 
• you do not know the reason for your hair loss 
• you are under 18 years of age. Do not use on babies and children
• your scalp is red, inflamed, infected, irritated, or painful 
• you use other medicines on the scalp

Ask a doctor before use if you have

heart disease

When using this product

• do not apply on other parts of the body
• avoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water
• some people have experienced changes in hair color and/or texture
• it takes time to regrow hair. You may need to use this product 2 times a day for at least 4 months before you see results
• the amount of hair regrowth is different for each person. This product will not work for all men.

Stop use and ask a doctor if

• chest pain, rapid heartbeat, faintness, or dizziness occurs 
• sudden, unexplained weight gain occurs
• your hands or feet swell
• scalp irritation or redness occurs
• unwanted facial hair growth occurs
• you do not see hair regrowth in 4 months

May be harmful if used when pregnant or breast-feeding.

Keep out of reach of children.

If swallowed, get medical help, or contact a Poison Control Center right away.

Directions

• apply one mL with dropper 2 times a day directly onto the scalp in the hair loss area
• using more or more often will not improve results 
• continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again

Other information

• see hair loss pictures on side of this carton
• before use, read all information on carton and enclosed leaflet 
• keep the carton. It contains important information.
• In clinical studies of mostly white women aged 18-45 years with mild to moderate degrees of hair loss, the following response to 2% minoxidil topical solution was reported: 19% of women reported moderate hair regrowth after using 2% minoxidil topical solution for 8 months (19% had moderate regrowth; 40% had minimal regrowth). This compares with 7% of women reporting moderate hair regrowth after using the placebo, the liquid without minoxidil in it, for 8 months (7% had moderate regrowth; 33% had minimal regrowth).
• store at controlled room temperature 20° to 25°C (68° to 77°F).

Inactive ingredients

Alcohol, Propylene Glycol, Purified Water

Questions or comments?

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Visit Website at misantoremedio.com

Package Labeling:

Package Labeling:

INGREDIENTS AND APPEARANCE

SANTO REMEDIO WOMENS HAIR REGROWTH TREATMENT MINOXIDIL UNSCENTED 
minoxidil solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81352-561
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1)	MINOXIDIL	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81352-561-00	1 in 1 BOX	11/08/2024
1		60 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2	NDC: 81352-561-03	3 in 1 BOX	11/08/2024
2		60 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA078176	11/08/2024

Labeler - SANTO REMEDIO LLC (117456185)

Establishment
Name	Address	ID/FEI	Business Operations
Pure Source, LLC		080354456	manufacture(81352-561)