Careone Hair Regrowth Treatment for Men

Generic Name: minoxidil

Dosage Form: solution
American Sales Company Hair Regrowth Treatment for Men Drug Facts

Active ingredient

Minoxidil 5% w/v

Purpose

Hair regrowth treatment for men

Uses

to regrow hair on the top of the scalp (vertex only, see pictures on side of carton)

Warnings

For external use only. For use by men only.

Flammable: Keep away from fire or flame

Do not use if

• you are a woman


• your amount of hair loss is different than that shown on the side of this carton or your hair loss is on the front of the scalp. Minoxidil topical solution 5% is not intended for frontal baldness or receding hairline.


• you have no family history of hair loss


• your 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 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. Results may occur at 2 months with twice a day usage. For some men, you may need to use this product 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.


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


• in clinical studies with mostly white men aged 18-49 years with moderate degrees of hair loss, minoxidil topical solution 5% for men provided more hair regrowth than minoxidil topical solution 2%


• store at 20° to 25°C (68° to 77°F). Keep tightly closed.

Inactive ingredients

alcohol, propylene glycol, purified water

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to the active ingredient in Men’s Rogaine® Extra Strength

Extra Strength

Minoxidil Topical Solution USP, 5%

Hair Regrowth Treatment

For Men

Clinically Proven to Help Regrow Hair

Revitalizes Hair Follicles

Unscented

Not for Use by Women

# Month Supply

Hair Regrowth Treatment for Men Carton

CAREONE HAIR REGROWTH TREATMENT  EXTRA STRENGTH minoxidil  solution

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 41520-798 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MINOXIDIL (MINOXIDIL) MINOXIDIL 3 g  in 60 mL

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color YELLOW (Light Amber) Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 41520-798-16 1 BOTTLE In 1 CARTON contains a BOTTLE 1 60 mL In 1 BOTTLE This package is contained within the CARTON (41520-798-16) 2 41520-798-30 3 BOTTLE In 1 CARTON contains a BOTTLE 2 60 mL In 1 BOTTLE This package is contained within the CARTON (41520-798-30)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075598	12/15/2009

Labeler - American Sales Company (809183973)

Revised: 06/2009American Sales Company

More Careone Hair Regrowth Treatment for Men resources

• Careone Hair Regrowth Treatment for Men Use in Pregnancy & Breastfeeding
• Careone Hair Regrowth Treatment for Men Drug Interactions
• Careone Hair Regrowth Treatment for Men Support Group
• 7 Reviews for Careone Hair Regrowth Treatment for Men - Add your own review/rating

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