ARTIFICIAL TEARS- carboxymethylcellulose sodium solution/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) (CARBOXYMETHYLCELLULOSE - UNII:05JZI7B19X)

Available from:

Aru Pharma Inc.

Administration route:

OPHTHALMIC

Prescription type:

OTC DRUG

Therapeutic indications:

Eye Lubricant - for use as a protectant against further irritation or to relieve dryness of the eye - for the temporary relief of discomfort due to minor irritations of the eye, or to exposure to wind or sun

Authorization status:

OTC monograph final

Summary of Product characteristics

ARTIFICIAL TEARS- CARBOXYMETHYLCELLULOSE SODIUM SOLUTION/ DROPS
ARU PHARMA INC.
_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._
----------
QPACK ARTIFICIAL TEARS
_DRUG FACTS_
ACTIVE INGREDIENT
Carboxymethylcellulose Sodium 10 MG in 1 ml.
PURPOSE
Eye Lubricant
_USES_
for use as a protectant against further irritation or to relieve
dryness of the eye
for the temporary relief of discomfort due to minor irritations of the
eye, or to
exposure to wind or sun
_WARNINGS_
FOR EXTERNAL USE ONLY
• DO NOT USE THIS PRODUCT IF solution changes color or becomes
cloudy
STOP USE AND ASK A DOCTOR IF YOU EXPERIENCE
• eye pain • changes in vision • continued redness or irritation
of the eye or if the
condition worsens or persists for more than 72 hours
WHEN USING THIS PRODUCT
• to avoid contamination, do not touch tip of container to any
surface • replace cap
after using. Keep container tightly closed.
• remove contact lens before using
KEEP OUT OF THE REACH OF CHILDREN. If accidentally swallowed, get
medical help or
contact a Poison Control Center immediately.
_DIRECTIONS_
Instill 1 or 2 drops in the affected eye(s) as needed.
_OTHER INFORMATION_
Tamper Evident. Do not use this product if neckband is missing or
broken.
RETAIN THIS CARTON FOR FUTURE REFERENCE
Store at 15°-30°C (59°-86°F)
_INACTIVE INGREDIENTS_
Boric Acid, Potassium Chloride, Sodium Chloride, Calcium Chloride
Dihydrate, Magnesium
Chloride, Sodium Chlorite, Sodium Hydroxide and Water for Injection
Compare to the active ingredient in Refresh Plus Eye drops
LUBRICANT EYE DROPS
Refresh, Lubricate and Moisturizes
Distributed by.
ARU PHARMA INC.
MOUNT VERNON, NY 10552
www.qpackrx.com
PACKAGING
Aru Pharma Inc.
ARTIFICIAL TEARS
carboxymethylcellulose sodium solution/ drops
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:70403-921
ROUTE OF ADMINISTRATION
OPHTHALMIC
ACTIVE INGR