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

Rohto

The Mentholatum Company

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients

Hypromellose 0.35%

Tetrahydrozoline hydrochloride 0.05%

Purpose

Hypromellose - Lubricant

Tetrahydrozoline hydrochloride - Redness reliever

Uses

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

Warnings

For external use only

Ask a doctor before use if you have narrow angle glaucoma

When using this product

  • •do not touch tip 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 at 25°C (77°F)
  • •tightly snap on cap to seal

Inactive ingredients

benzalkonium chloride, boric acid, chlorobutanol, edetate disodium, menthol, polysorbate 80, potassium aspartate, purified water, pyridoxine hydrochloride, sodium borate

Questions or comments?

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

Package/Label Principal Display Panel

Rohto Arctic Redness Relief

Redness Reliever, Lubricant Eye Drops

Principal Display Panel

Rohto

Hypromellose, Tetrahydrozoline hydrochloride LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:10742-8144
Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
HYPROMELLOSES 3.5 mg
TETRAHYDROZOLINE HYDROCHLORIDE TETRAHYDROZOLINE .5 mg

Inactive Ingredients

Ingredient Name Strength
benzalkonium chloride
BORIC ACID
chlorobutanol
EDETATE DISODIUM
MENTHOL
polysorbate 80
POTASSIUM ASPARTATE
water
PYRIDOXINE HYDROCHLORIDE
SODIUM BORATE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 13 in 1 BOTTLE, WITH APPLICATOR
2 NDC:10742-8144-1 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part349 2006-08-24


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