Rohto description, usages, side effects, indications, overdosage, supplying and lots more!

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Rohto

The Mentholatum Company

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients

Naphazoline hydrochloride 0.012%

Polysorbate 80 0.2%

Purpose

Naphazoline hydrochloride - Redness reliever

Polysorbate 80 - Lubricant

Rohto Uses

  • •relieves redness of the eye due to minor eye irritations
  • •temporarily relieves burning and irritation due to dryness of the eye

Warnings

For external use only

Ask a doctor before use if you have

narrow angle glaucoma

When using this product

  • •do not touch top of container to any surface to avoid contamination
  • •replace cap after each use
  • •do not use if solution changes color or becomes cloudy
  • •overuse may cause more eye redness
  • •pupils may become enlarged temporarily
  • •remove contact lenses before using

Stop use and ask a doctor if

  • •you feel eye pain
  • •changes in vision occur
  • •redness or irritation of the eyes lasts
  • •condition worsens or lasts more than 72 hours

Keep out of reach of children.

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

Directions

put 1 or 2 drops in the affected eye(s) up to 4 times daily

Other information

  • •do not store above 25°C (77°F)
  • •tightly snap on cap to seal

Inactive ingredients

alcohol (0.1%), benzalkonium chloride, boric acid, chlorobutanol, edetate disodium, menthol, purified water, sodium borate

Questions?

Toll free 1-877-636-2677 MON-FRI 9 AM to 5 PM (EST)

Package/Label Principal Display Panel

Principal Display Panel

Rohto

Naphazoline hydrochloride, Polysorbate 80 LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:10742-8142
Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
naphazoline hydrochloride Naphazoline .12 mg
polysorbate 80 2 mg

Inactive Ingredients

Ingredient Name Strength
ALCOHOL
benzalkonium chloride
BORIC ACID
chlorobutanol
EDETATE DISODIUM
MENTHOL
water
SODIUM BORATE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 13 in 1 BOTTLE, WITH APPLICATOR
2 NDC:10742-8142-2 7 in 1 BOTTLE, WITH APPLICATOR

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part349 2001-08-21


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Be sure to consult your doctor before taking any medication!
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