Sato Clear

Sato Clear
SPL v7
SPL
SPL Set ID e0317a10-7b94-41c8-8d2b-0e3b6fc4ef60
Route
OPHTHALMIC
Published
Effective Date 2014-02-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Naphazoline (12 mg)
Inactive Ingredients
Camphor (synthetic) Benzalkonium Chloride Sodium Chloride Boric Acid Sodium Borate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 1989-05-31

Description

Active ingredient Naphazoline hydrochloride 0.012%


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses relieves this symptom due to minor eye irritations

■ redness of the eye

Dosage and Administration

Directions

■ Place 1 or 2 drops in the affected eyes up to 4 times daily.

Description

Active ingredient Naphazoline hydrochloride 0.012%

Section 50565-1

Keep out of reach of children.

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



Section 50566-9

Stop use and ask a doctor if you experience

  • eye pain
  • changes in vision
  • continued redness or irritation of the eye
  • the condition worsens or persists for more than 72 hours
Section 50567-7

When using this product

  • pupils may become enlarged temporarily
  • overuse of this product may produce increased redness of the eyes
  • to avoid contamination, do not touch tip of container to any surface
  • replace cap after using
Section 50569-3

Ask a doctor before use if you have

  • narrow angle glaucoma
Section 50570-1

Do not use

  • if solution changes color or becomes cloudy
Section 51727-6

Inactive ingredients benzalkonium chloride, boric acid, dl-camphor, sodium borate, sodium chloride, purified water.

Section 51945-4

Section 55105-1

Purpose

Naphazoline hydrochloride      Vasoconstrictor

Section 55106-9

Active ingredient

Naphazoline hydrochloride 0.012%

Section 60561-8

Other information

  • use only if imprinted tamper-resistant seal on the bottle cap is intact
  • keep container tightly closed

     

Structured Label Content

Indications and Usage (34067-9)

Uses relieves this symptom due to minor eye irritations

■ redness of the eye

Dosage and Administration (34068-7)

Directions

■ Place 1 or 2 drops in the affected eyes up to 4 times daily.

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 50565-1 (50565-1)

Keep out of reach of children.

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



Section 50566-9 (50566-9)

Stop use and ask a doctor if you experience

  • eye pain
  • changes in vision
  • continued redness or irritation of the eye
  • the condition worsens or persists for more than 72 hours
Section 50567-7 (50567-7)

When using this product

  • pupils may become enlarged temporarily
  • overuse of this product may produce increased redness of the eyes
  • to avoid contamination, do not touch tip of container to any surface
  • replace cap after using
Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • narrow angle glaucoma
Section 50570-1 (50570-1)

Do not use

  • if solution changes color or becomes cloudy
Section 51727-6 (51727-6)

Inactive ingredients benzalkonium chloride, boric acid, dl-camphor, sodium borate, sodium chloride, purified water.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Naphazoline hydrochloride      Vasoconstrictor

Section 55106-9 (55106-9)

Active ingredient

Naphazoline hydrochloride 0.012%

Section 60561-8 (60561-8)

Other information

  • use only if imprinted tamper-resistant seal on the bottle cap is intact
  • keep container tightly closed

     

Advanced Ingredient Data


Raw Label Data

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