Sato Clear

Dosage form: solution/ drops
Ingredients: NAPHAZOLINE HYDROCHLORIDE 12mg in 100mL
Labeler: Sato Pharmaceutical Co., Ltd.
NDC Code: 49873-044

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

DRUG FACTS

Active ingredient
Naphazoline hydrochloride 0.012%

Purpose
Naphazoline hydrochloride      Vasoconstrictor

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

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

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

Other information

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

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

SATO CLEAR 
naphazoline hydrochloride solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49873-044
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPHAZOLINE HYDROCHLORIDE (NAPHAZOLINE) NAPHAZOLINE HYDROCHLORIDE12 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CAMPHOR (SYNTHETIC) 
BENZALKONIUM CHLORIDE 
SODIUM CHLORIDE 
BORIC ACID 
SODIUM BORATE 
WATER 
Packaging
#Item CodePackage Description
1NDC:49873-044-011 BOTTLE, PLASTIC in 1 CARTON
115 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34905/31/1989
Labeler - Sato Pharmaceutical Co., Ltd. (690575642)
Establishment
NameAddressID/FEIOperations
Sato Pharmaceutical Co., Ltd.715699133manufacture(49873-044), label(49873-044), pack(49873-044)

Revised: 02/2014
 
Sato Pharmaceutical Co., Ltd.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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