FDA Label for Rohto All-in-one

View Indications, Usage & Precautions

Rohto All-in-one Product Label

The following document was submitted to the FDA by the labeler of this product The Mentholatum Company. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredients



Hypromellose 0.2%

Tetrahydrozoline HCl 0.05%

Zinc sulfate 0.25%


Purpose



Hypromellose - Lubricant

Tetrahydrozoline HCl - Redness reliever

Zinc sulfate - Astringent


Uses



  • •temporarily relieves redness of the eye and discomfort due to
    • ∘minor eyes irritations
    • ∘exposure to wind or sun
    • •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 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

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
  • •tightly snap on cap to seal
  • Other information

    • •store at 20-25°C (68-77°F)

Inactive Ingredients



boric acid, edetate disodium, menthol, polysorbate 80, purified water, sodium borate


Questions?



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


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