SATO CLEAR- naphazoline hydrochloride solution/ drops

Sato Clear by

Drug Labeling and Warnings

Sato Clear by is a Otc medication manufactured, distributed, or labeled by Sato Pharmaceutical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient
Naphazoline hydrochloride 0.012%

PURPOSE

Purpose
Naphazoline hydrochloride      Vasoconstrictor

INDICATIONS & USAGE

Uses relieves this symptom due to minor eye irritations
■ redness of the eye

WARNINGS

Warnings

For external use only

Do not use

• if solution changes color or becomes cloudy

Ask a doctor before use if you have

• narrow angle glaucoma

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

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

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.

DOSAGE & ADMINISTRATION

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

OTHER SAFETY INFORMATION

Other information

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

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SATO CLEAR 
naphazoline hydrochloride solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49873-044
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV)	NAPHAZOLINE HYDROCHLORIDE	12 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
BORIC ACID (UNII: R57ZHV85D4)
SODIUM BORATE (UNII: 91MBZ8H3QO)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49873-044-01	1 in 1 CARTON	05/31/1989
1		15 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	05/31/1989

Labeler - Sato Pharmaceutical Co., Ltd. (690575642)

Establishment
Name	Address	ID/FEI	Business Operations
Sato Pharmaceutical Co., Ltd.		715699133	manufacture(49873-044) , label(49873-044) , pack(49873-044)