drug facts - rohto dual light relief

drug facts - rohto dual light relief
SPL v2
SPL
SPL Set ID 1bbde83e-a64e-1a0f-e063-6394a90af4ff
Route
ophthalmic
Published
Effective Date 2024-05-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
povidone (5 mg) hypromellose, unspecified (3 mg)
Inactive Ingredients
chlorobutanol water taurine trisodium citrate dihydrate camphor (synthetic) boric acid zinc sulfate heptahydrate polysorbate 80 levomenthol edetate disodium alginic acid anhydrous citric acid sodium borate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-05-30

Purpose

Hypromellose – Lubricant Povidone - Lubricant

Description

Hypromellose 0.3% Povidone 0.5%


Medication Information

Warnings

For external use only

Uses
  • for the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun
  • protects against further irritation or to relieve dryness of the eye

Purpose

Hypromellose – Lubricant

Povidone - Lubricant

Directions
  • put 1 or 2 drops in the affected eye(s) as needed
  • tightly snap on cap to seal

Other information

  • do not store above 25 OC (77 OF)
Inactive Ingredients

alginic acid, anhydrous citric acid, boric acid, camphor, chlorobutanol, edetate disodium, menthol, polysorbate 80, purified water, sodium borate, sodium citrate, taurine, zinc sulfate

Description

Hypromellose 0.3% Povidone 0.5%

Principal Display Panel

Questions?

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

Section 51945-4

Active Ingredient

Hypromellose 0.3%

Povidone 0.5%

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
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 persists for more than 72 hours
Keep Out of Reach of Children.

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


Structured Label Content

Warnings

For external use only

Uses
  • for the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun
  • protects against further irritation or to relieve dryness of the eye

Purpose

Hypromellose – Lubricant

Povidone - Lubricant

Directions
  • put 1 or 2 drops in the affected eye(s) as needed
  • tightly snap on cap to seal

Other information

  • do not store above 25 OC (77 OF)
Inactive Ingredients (Inactive ingredients)

alginic acid, anhydrous citric acid, boric acid, camphor, chlorobutanol, edetate disodium, menthol, polysorbate 80, purified water, sodium borate, sodium citrate, taurine, zinc sulfate

Principal Display Panel

Questions?

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

Section 51945-4 (51945-4)

Active Ingredient (Active ingredient)

Hypromellose 0.3%

Povidone 0.5%

When Using This Product (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
Stop Use and Ask A Doctor If (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 persists for more than 72 hours
Keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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